Negative pressure wound closure device

ABSTRACT

The present invention relates to a negative pressure wound closure system and methods for using such a system. Preferred embodiments of the invention facilitate closure of the wound by preferentially contracting to provide for movement of the tissue. Preferred embodiments can utilize tissue securing portions that aid in securing the invention within a wound.

CROSS-REFERENCE TO RELATED APPLICATIONS

The application claims the benefit of U.S. Provisional Application No.61/893,821, filed Oct. 21, 2013, entitled TISSUE ANCHORING DEVICE, U.S.Provisional Application No. 61/913,210, filed Dec. 6, 2013, entitledTEARABLE WOUND TREATMENT AND CLOSURE DEVICES, U.S. ProvisionalApplication No. 61/930,414, filed Jan. 22, 2014, entitled NEGATIVEPRESSURE WOUND CLOSURE DEVICE, U.S. Provisional Application No.61/930,436, filed Jan. 22, 2014, entitled NEGATIVE PRESSURE WOUNDCLOSURE DEVICE, U.S. Provisional Application No. 61/930,426, filed Jan.22, 2014, entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE, U.S.Provisional Application No. 61/930,427, filed Jan. 22, 2014, entitledNEGATIVE PRESSURE WOUND CLOSURE DEVICE, U.S. Provisional Application No.61/930,423, filed Jan. 22, 2014, entitled NEGATIVE PRESSURE WOUNDCLOSURE DEVICE, U.S. Provisional Application No. 61/930,913, filed Jan.23, 2014, entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE, and U.S.Provisional Application No. 62/051,834, filed Sep. 17, 2014, entitledNEGATIVE PRESSURE WOUND CLOSURE DEVICE. The contents of theaforementioned applications are hereby incorporated by reference intheir entireties as if fully set forth herein. The benefit of priorityto the foregoing applications is claimed under the appropriate legalbasis, including, without limitation, under 35 U.S.C. § 119(e).

BACKGROUND OF THE INVENTION Field of the Invention

This application describes embodiments of apparatuses, methods, andsystems for the treatment of wounds, specifically to aid in the closureof large wounds, in conjunction with the administration of negativepressure.

Description of the Related Art

Negative pressure wound therapy has been used in the treatment ofwounds, and in many cases can improve the rate of healing while alsoremoving exudates and other deleterious substances from the wound site.

Abdominal compartment syndrome is caused by fluid accumulation in theperitoneal space due to edema and other such causes, and results ingreatly increased intra-abdominal pressure that may cause organ failureeventually resulting in death. Causes may include sepsis or severetrauma. Treatment of abdominal compartment syndrome may require anabdominal incision to permit decompression of the abdominal space, andas such, a large wound may be created onto the patient. Closure of thiswound, while minimizing the risk of secondary infections and othercomplications, and after the underlying edema has subsided, then becomesa priority. However, acute open abdominal conditions may be caused byother reasons in addition to compartment syndrome, as described furtherbelow.

Other large or incisional wounds, either as a result of surgery, trauma,or other conditions, may also require closure. For example, woundresulting from sterniotomies, fasciotomies, and other abdominal woundsmay require closure. Wound dehiscence of existing wounds is anothercomplication that may arise, possibly due to incomplete underlyingfascial closure, or secondary factors such as infection.

Existing negative pressure treatment systems, while permitting eventualwound closure, still require lengthy closure times. Although these maybe combined with other tissue securement means, such as sutures, thereis also a risk that underlying muscular and fascial tissue is notappropriately reapproximated so as to permit complete wound closure.Further, when foam or other wound fillers are inserted into the wound,the application of negative pressure to the wound and the foam may causeatmospheric pressure to bear down onto the wound, compressing the foamdownward and outward against the margins of the wound. This downwardcompression of the wound filler slows the healing process and slows orprevents the joining of wound margins. Additionally, inflammation of thefascia in the form of certain types of fasciitis can lead to rapid andexcessive tissue loss, potentially meriting the need for more advancednegative pressure treatment systems. Accordingly, there is a need toprovide for an improved apparatus, method, and system for the treatmentand closure of wounds.

SUMMARY OF THE INVENTION

Embodiments of the present invention relate to negative pressure woundclosure devices, methods, and systems that facilitate closure of awound. It will be understood by one of skill in the art that the woundsdescribed herein this specification may encompass any wound, and are notlimited to a particular location or type of wound. The devices, methods,and systems may operate to reduce the need for repetitive replacement ofwound filler material currently employed and can advance the rate ofhealing. The devices, methods, and systems may be simultaneously usedwith negative pressure to remove wound fluids.

In one embodiment, an apparatus for treating a wound with negativepressure wound therapy may comprise:

-   -   a stabilizing structure for insertion into or over a wound, the        stabilizing structure configured to collapse under negative        pressure, the stabilizing structure having a length extending        along a central longitudinal axis of the stabilizing structure,        a width transverse to the length extending along a central        transverse axis of the stabilizing structure, and a thickness        transverse to the length and the width, wherein the length and        width are greater than the thickness, and wherein the        stabilizing structure comprises:        -   a first side and a second side extending the length of the            stabilizing structure, and a third side and a fourth side            extending the width of the stabilizing structure, wherein            the first side is opposite the second side and the third            side is opposite the fourth side, and wherein the first side            and the second side are curved or bent outwardly relative to            the central longitudinal axis to provide an outer perimeter            of the stabilizing structure with an at least partially            elliptical shape;        -   a plurality of elongate strips extending the length of the            stabilizing structure from the third side to the fourth            side, wherein the plurality of elongate strips comprise            outermost elongate strips defining the first and second            sides of the stabilizing structure and a plurality of inner            elongate strips positioned between the outermost elongate            strips;        -   a plurality of intervening members connecting the elongate            strips, wherein the plurality of intervening members are            configured to pivot relative to the strips to allow the            plurality of elongate strips to collapse relative to one            another; and        -   a plurality of cells provided side-by-side in a horizontal            plane parallel to the length and width of the stabilizing            structure, each cell defined by a plurality of walls            extending in a vertical direction perpendicular to the            horizontal plane and formed by either the elongate strips or            the intervening members, each cell having a top end and a            bottom end with an opening extending through the top and            bottom ends;        -   wherein the stabilizing structure is configured to collapse            more in the horizontal plane than in the vertical direction            by collapsing the plurality of cells.

In some embodiments, the length of the stabilizing structure is greaterthan the width of the stabilizing structure. The third and fourth sidesmay form a zig-zag shape defined by intervening members between adjacentelongate strips. The stabilizing structure may be symmetrical about thecentral longitudinal axis. The stabilizing structure may be symmetricalabout the central transverse axis. Some embodiments may call for astraight, central inner elongate strip provided along the centrallongitudinal axis of the stabilizing structure. In certain embodiments,the apparatus may comprise a plurality of straight inner elongatestrips. The apparatus may comprise inner elongate strips provided onopposite sides of the longitudinal axis that are curved or bentoutwardly relative to the longitudinal axis. In certain embodiments,each of the elongate strips may be arranged in semi-parallel. In someembodiments, some of the cells are diamond-shaped. Some of thediamond-shaped cells may be subdivided from larger diamond-shaped cells.In some embodiments, some of the cells are parallelpiped-shaped. Incertain embodiments, the stabilizing structure may comprise a pluralityof cells having four sides, wherein the dimensions of each of the cellshaving four sides is defined by the formula a+b=c+d, wherein a, b, c andd are the lengths of individual sides of the cell, and wherein lengths aand c are provided on adjacent elongate strips defining the cell andlengths b and d are provided on adjacent intervening members definingthe cell. In some embodiments, the lengths of the cells along anelongate strip are progressively longer toward the central transverseaxis. In certain embodiments, a lower portion of the stabilizingstructure is concave. In some embodiments, an upper portion of thestabilizing structure is convex. In some embodiments, the stabilizingstructure may be is tearable. The stabilizing structure may furthercomprise weakened sections, the weakened sections configured to be torn.

In another embodiment, an apparatus for treating a wound with negativepressure wound therapy comprises:

-   -   a stabilizing structure for insertion into or over a wound, the        stabilizing structure configured to collapse under negative        pressure;    -   wherein the stabilizing structure has a concave surface along at        least a lower portion of the stabilizing structure.

The stabilizing structure may further comprise:

-   -   a plurality of cells provided side-by-side, each cell defined by        one or more walls, each cell having a top end and a bottom end        with an opening extending through the top and bottom ends;    -   wherein the stabilizing structure is configured to collapse by        collapsing one or more cells.

In some embodiments, the stabilizing structure may have an outerperimeter that defines an at least partially elliptical shape.

In another embodiment, an apparatus for treating a wound with negativepressure wound therapy comprises:

-   -   a stabilizing structure for insertion into or over a wound, the        stabilizing structure configured to collapse under negative        pressure, wherein the stabilizing structure comprises:    -   a plurality of cells provided side-by-side, each cell defined by        one or more walls, each cell having a top end and a bottom end        with an opening extending through the top and bottom ends;    -   wherein the stabilizing structure is configured to collapse by        collapsing one or more cells;    -   wherein the stabilizing structure has an outer perimeter        defining an at least partially elliptical shape.

In certain embodiments, the stabilizing structure comprises:

-   -   a plurality of elongate strips; and    -   a plurality of intervening members connecting the elongate        strips, wherein the plurality of intervening members are        configured to pivot relative to the strips to allow the        plurality of elongate strips to collapse relative to one        another.

The stabilizing structure may comprise one or more rows of cells betweenadjacent strips configured to collapse in a first direction, and one ormore rows of cells between adjacent strips configured to collapse in asecond direction opposite the first direction. The elongate strips canbe parallel to each other and/or they may be curved along their lengths.In certain embodiments, at least some of the elongate strips may becurved along their lengths outward away from a center of the stabilizingstructure. Some of the elongate strips may be connected at their ends.Some of the elongate strips may have regions of increased flexibility toallow for lengthening or shortening of the elongate strips. In certainembodiments, a lower portion of the stabilizing structure may be concavein a first horizontal direction and a second horizontal directionperpendicular to the first horizontal direction. In some embodiments, anupper portion of the stabilizing structure is convex along at least anupper portion of the stabilizing structure. An upper portion of thestabilizing structure may be convex in a first horizontal direction anda second horizontal direction perpendicular to the first horizontaldirection. In certain embodiments, the stabilizing structure may bepre-formed to have either or both of a concave lower surface and aconvex upper surface. The stabilizing structure can have an outerperimeter defining a bi-elliptical shape. In some embodiments, thestabilizing structure is configured to be placed into an abdominal woundand conform to the shape of internal organs. In some embodiments, theapparatus may comprise one or more wound covers configured to be placedover the stabilizing structure to maintain negative pressure over thewound. The apparatus may further comprise a negative pressure portconfigured to deliver negative pressure to the stabilizing structure tocause the stabilizing structure to collapse. In certain embodiments, theapparatus can comprise a negative pressure source configured to delivernegative pressure to the stabilizing structure to cause the stabilizingstructure to collapse.

In another embodiment, an apparatus for treating a wound comprises:

-   -   a wound filler comprising an initial elliptical shape having a        first curved side and a second curved side opposite the first        curved side; and    -   a first plurality of designated pre-cut lines formed in the        wound filler, wherein each of said pre-cut lines intersects the        second curved side of the wound filler and has a curvature        following that of the first curved side such that removal of a        portion of the wound filler along one of the designated pre-cut        lines provides a remaining wound filler having a smaller        elliptical shape than the initial elliptical shape.

The wound filler may comprise a porous material. In some embodiments,the wound filler can comprise a stabilizing structure. Some embodimentsmay call for the apparatus to further comprise a second plurality ofdesignated pre-cut lines that intersect with the first plurality ofdesignated pre-cut lines, the first curved side and the second curvedside. In certain embodiments, the apparatus may further comprise anchorsprovided on the second curved side.

In another embodiment, a wound closure device may comprise:

-   -   a stabilizing structure for insertion into a wound, the        stabilizing structure having a length, a width transverse to the        length and a thickness transverse to the length and the width,        wherein the length and width are greater than the thickness, and        wherein the stabilizing structure comprises an outer perimeter        comprising at least one outer wall, and wherein the stabilizing        structure is configured to collapse more in a horizontal plane        parallel to the length and width of the stabilizing structure        than in a vertical plane perpendicular to the horizontal plane;        and    -   at least one stabilizing clip attachable to the outer wall of        the stabilizing structure, the stabilizing clip configured to        extend outward into the surrounding tissue and prevent the        stabilizing structure from lifting upwards in a direction out of        the wound.

In some embodiments, the stabilizing structure may comprise a pluralityof cells provided side-by-side, each cell defined by one or more walls,each cell having a top end and a bottom end with an opening extendingthrough the top and bottom ends, and wherein the stabilizing structureis configured to collapse by collapsing one or more cells. The junctionsbetween the walls of the stabilizing structure can be thinned andconfigured to rotate.

In some embodiments, the stabilizing structure may comprise:

-   -   a plurality of elongate strips; and    -   a plurality of intervening members connecting the elongate        strips, wherein the plurality of intervening members are        configured to pivot relative to the strips to allow the        plurality of elongate strips to collapse relative to one        another.

The stabilizing structure may have a first side and a second sideextending along the length of the stabilizing structure, and a thirdside and a fourth side extending along the width of the stabilizingstructure, wherein the first side is opposite the second side and thethird side is opposite the fourth side. In some embodiments, the firstand second sides define flat surfaces that are parallel to each other.The first and second sides may define a curved shape. The third andfourth sides may comprise a zig-zag shape. In some embodiments thestabilizing clip is rigid. In certain embodiments there may be more thanone stabilizing clip. The stabilizing clip may comprise an attachmentportion configured to clip to a wall of the stabilizing structure and asecuring portion that extends outward from the attachment portion in ahorizontal direction. The securing portion may extend from a lower endof the attachment portion. The securing portion may extend from an upperend of the attachment portion. In some embodiments, the stabilizing clipcomprises a first securing portion extending outward from an upper endof the attachment portion and a second securing portion extendingoutward from a lower end of the attachment portion. The stabilizing clipmay be attached to the outer wall of the stabilizing structure. Thestabilizing clip can comprise a recess where the securing portionextends from the attachment portion. In some embodiments, the attachmentportion is configured to loop over the outer wall of the stabilizingstructure, and the attachment portion comprises a foot at an end of theloop of the attachment portion. The securing portion can comprisegrippers configured to extend into the surrounding tissue.

In another embodiment, a method of treating a wound comprises:

-   -   providing a stabilizing structure, the stabilizing structure        defining an initial outer perimeter;    -   sizing the stabilizing structure to a desired dimension, wherein        after sizing the stabilizing structure has a final outer        perimeter;    -   attaching a stabilizing clip to the outside of the stabilizing        structure, the stabilizing clip comprising a securing portion        extending horizontally outward from the stabilizing structure;        and    -   inserting the stabilizing structure into the wound, wherein        after insertion the securing portion of the stabilizing clip        engages tissue to prevent the stabilizing structure from lifting        upwards in a direction out of the wound.

In some embodiments, the method may further comprise:

-   -   covering the stabilizing structure with at least one drape        sealed to skin surrounding the wound; and    -   applying negative pressure through the at least one drape to the        wound via a source of negative pressure, wherein the application        of negative pressure causes the stabilizing structure to        horizontally collapse.

The method may comprise inserting a tissue protection layer over thewound before inserting the stabilizing structure. In some embodiments,the securing portion of the stabilizing clip extends below tissuesurrounding the stabilizing structure. The securing portion of thestabilizing clip may comprise at least one gripper configured to extendinto tissue surrounding the stabilizing structure. The stabilizing clipmay be attached to the stabilizing structure with an attachment portionthat loops over the outside of the stabilizing structure, the attachmentportion comprising a foot at an end of the loop of the attachmentportion. The stabilizing clip can comprise a recess where the securingportion extends horizontally from the stabilizing clip. In certainembodiments a plurality of stabilizing clips may be attached to theoutside of the stabilizing structure.

In another embodiment, a wound closure device comprises:

-   -   a stabilizing structure;    -   a porous layer configured to at least partially surround a        perimeter of the stabilizing structure; and    -   an anchoring layer comprising anchors configured to at least        partially surround the layer of porous material when the layer        of porous material at least partially surrounds the stabilizing        structure, wherein the anchors are configured to attach to        tissues within the wound.

In some embodiments, the anchors may comprise any type of anchorsubstantially described herein this application. In certain embodiments,the wound closure device can comprise layers of foam above and below thestabilizing structure. The anchors can comprise at least two differenttypes of anchors as described herein this application. In certainembodiments, the anchoring layer comprises a plurality of bandscomprising different types of anchors as described herein thisapplication.

In some embodiments, the anchoring layer may comprise a first band of afirst type of anchors configured to be positioned above a second band ofa second type of anchors. In some embodiments, each band comprisesbetween 1 and 30 individual rows of anchors. The anchoring layer cancomprise a plurality of alternating bands of different types of anchorsas substantially described herein this specification. In someembodiments, the anchors are biodegradable. The anchors can comprise anyof the biodegradable materials substantially described herein thisspecification. In further embodiments, the anchors may be configured topenetrate any of the tissue types as substantially described herein thisspecification.

In another embodiment, a method of closing a wound comprises: shaping afirst layer of foam into the shape of the wound;

-   -   placing the first layer of foam in the wound;    -   shaping a stabilizing structure into the shape of the wound;    -   attaching a ribbon of foam to the perimeter of the stabilizing        structure to at least partially surround the perimeter of the        stabilizing structure;    -   attaching an anchoring layer comprising anchors to the foam        ribbon;    -   placing the stabilizing structure with the ribbon of foam and        the anchoring layer into the wound, wherein placing the        stabilizing structure comprises first horizontally compressing        the stabilizing structure and allowing the stabilizing structure        to expand once within the wound to cause the anchors to engage        tissue;    -   covering the stabilizing structure with a second layer of foam;    -   covering the stabilizing structure with at least one drape        sealed to skin surrounding the wound; and    -   applying negative pressure through the at least one drape to the        wound via a source of negative pressure, wherein the application        of negative pressure causes the stabilizing structure to        horizontally collapse with the anchors engaging tissue.

In another embodiment, a wound closure device comprises:

-   -   a stabilizing structure for insertion into a wound, the        stabilizing structure having a length, a width transverse to the        length and a thickness transverse to the length and the width,        wherein the length and width are greater than the thickness, and        wherein the stabilizing structure comprises an outer perimeter        comprising at least one outer wall;    -   a first porous layer pre-attached to only part of the outer        perimeter of the stabilizing structure; and    -   a second porous layer separate from the first porous layer        configured to be attached to a remaining outer perimeter of the        stabilizing structure after the stabilizing structure has been        appropriately sized.

In certain embodiments, the stabilizing structure may have a first sideand a second side extending along the length of the stabilizingstructure, and a third side and a fourth side extending along the widthof the stabilizing structure, wherein the first side is opposite thesecond side and the third side is opposite the fourth side. In someembodiments, the first porous layer is pre-attached only to the firstside and the third side. In particular embodiments, the wound closuredevice may further comprise a plurality of anchors attached to at leasta portion of the porous layer pre-attached to only part of the outerperimeter of the stabilizing structure. The device may further comprisea plurality of anchors attached only to a portion of the first porouslayer pre-attached to the first side. In some embodiments, the devicemay further comprise a plurality of anchors attached to at least aportion of the second porous layer. The stabilizing structure cancomprise opposing sides that define flat surfaces that are parallel toeach other, wherein the first porous layer is pre-attached to one of theparallel opposing sides. The stabilizing structure can comprise opposingsides having a straight, curved or zig-zag shape, wherein the firstporous layer is pre-attached to one of the opposing sides having thestraight, curved or zig-zag shape. In some embodiments, the stabilizingstructure may have a constant thickness defined between upper and lowersurfaces of the stabilizing structure.

In certain embodiments, the stabilizing structure may comprise:

-   -   a plurality of cells provided side-by-side, each cell defined by        one or more walls, each cell having a top end and a bottom end        with an opening extending through the top and bottom ends;    -   wherein the stabilizing structure is configured to collapse by        collapsing one or more cells.

In particular embodiments, the stabilizing structure comprises:

-   -   a plurality of elongate strips; and    -   a plurality of intervening members connecting the elongate        strips, wherein the plurality of intervening members are        configured to pivot relative to the strips to allow the        plurality of elongate strips to collapse relative to one        another.

In further embodiments, the stabilizing structure may comprise one ormore rows of cells between adjacent strips configured to collapse in afirst direction, and one or more rows of cells between adjacent stripsconfigured to collapse in a second direction opposite the firstdirection. The wound closure device may further comprise a porous layerattached to a lower surface of the stabilizing structure. In certainembodiments, the wound closure device may further comprise a porouslayer attached to an upper surface of the stabilizing structure. Incertain embodiments, the porous layer(s) attached to the lower and/orupper surface of the stabilizing structure comprises protrusionsconfigured to extend into openings in the stabilizing structure. Thelength of the wound closure device may be greater than the width.

In another embodiment, a method of treating a wound, comprises:

-   -   providing a stabilizing structure, the stabilizing structure        defining an initial outer perimeter and having a first porous        layer attached to only a portion of the initial outer perimeter;    -   sizing the stabilizing structure to a desired dimension, wherein        after sizing the stabilizing structure has a final outer        perimeter that includes the portion of the initial outer        perimeter having the first porous layer attached thereto, and an        exposed portion where the first porous layer is not attached;        and    -   attaching a second porous layer to the exposed portion of the        final outer perimeter;    -   inserting the stabilizing structure into the wound.

The first porous layer may comprise a plurality of anchors. In someembodiments, the second porous layer can comprise a plurality ofanchors.

In some embodiments, the method can further comprise:

-   -   covering the stabilizing structure with at least one drape        sealed to skin surrounding the wound; and    -   applying negative pressure through the at least one drape to the        wound via a source of negative pressure, wherein the application        of negative pressure causes the stabilizing structure to        horizontally collapse.

In certain embodiments, the stabilizing structure may have a porouslayer attached to one or both of an upper and lower surface thereof. Themethod may further comprise inserting a tissue protection layer over thewound before inserting the stabilizing structure.

In another embodiment, a wound closure device comprises:

-   -   a stabilizing structure for insertion into a wound; and    -   a porous layer configured to be attached to at least a portion        of an outer perimeter of the stabilizing structure, wherein the        porous layer comprises a lower lip portion configured to extend        outwardly from the stabilizing structure beneath tissue        surrounding the wound and an upper lip portion configured to        extend outwardly from the stabilizing structure over tissue        surrounding the wound.

The lower lip portion and the upper lip portion can comprise adhesive.The porous layer can comprises a plurality of anchors configured toengage tissue surrounding the wound. Some of the plurality of anchorsmay be provided on the lower lip portion and the upper lip portion. Thelower lip may be configured to extend beneath the fascia. In certainembodiments, the upper lip is configured to extend over the dermis.

In another embodiment, a method of treating a wound comprises:

-   -   positioning a stabilizing structure as described herein this        specification into a wound with the lower lip extending        outwardly from the stabilizing structure beneath tissue        surrounding the wound and the upper lip extending outwardly from        the stabilizing structure over tissue surrounding the wound.

In particular embodiments, the method may further comprise:

-   -   covering the stabilizing structure with at least one drape        sealed to skin surrounding the wound; and    -   applying negative pressure through the at least one drape to the        wound via a source of negative pressure, wherein the application        of negative pressure causes the stabilizing structure to        horizontally collapse.

The stabilizing structure can have a porous layer attached to one orboth of an upper and lower surface thereof. In some embodiments, themethod further comprises inserting a tissue protection layer over thewound before inserting the stabilizing structure.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure; and    -   a mechanism configured to maintain the stabilizing structure in        a collapsed configuration after negative pressure has been        removed.

In certain embodiments, the stabilizing structure comprises:

-   -   a plurality of cells provided side-by-side, each cell defined by        one or more walls, each cell having a top end and a bottom end        with an opening extending through the top and bottom ends; and    -   wherein the stabilizing structure is configured to collapse by        collapsing one or more cells.

The stabilizing structure may comprise:

-   -   a plurality of elongate strips; and    -   a plurality of intervening members connecting the elongate        strips, wherein the plurality of intervening members are        configured to pivot relative to the strips to allow the        plurality of elongate strips to collapse relative to one        another.

In certain embodiments, the mechanism comprises one or more latchingmembers attached to one or more of the strips of the stabilizingstructure, the latching members configured to latch onto an adjacentstrip when the stabilizing structure moves to a collapsed position. Theone or more latching members may comprise a latching element thatlatches to said adjacent strip. In certain embodiments, the latchingelement comprises multiple teeth, each of the teeth configured to latchonto said adjacent strip when the stabilizing structure is in adifferent collapsed or compressed position. The latching element may bedisposed at an intermediate position along an elongate member of thelatching member, the latching element configured to pass through anopening in said adjacent strip to latch the latching member to saidadjacent strip. The device may further comprise a release mechanismcomprising an arch portion interconnecting adjacent latching members,the arch portion configured to receive a force thereon to lift thelatching members from engagement with said adjacent strip of thestabilizing structure. The mechanism can comprise one or more firstlatching members attached to one or more of the strips of thestabilizing structure and one or more second latching members attachedto one or more of the intervening members of the stabilizing structure,the first latching members configured to contact the second latchingmembers when the stabilizing structure moves to the collapsedconfiguration. The first latching members may extend at anon-perpendicular angle relative to their corresponding strips andwherein the second latching members extend at a non-perpendicular anglerelative to their corresponding intervening members.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure, the stabilizing structure comprising:        -   a plurality of elongate strips; and        -   a plurality of intervening members connecting the elongate            strips,    -   wherein the plurality of intervening members are configured to        pivot relative to the strips to allow the plurality of elongate        strips to collapse relative to one another; and    -   a mechanism configured to maintain the stabilizing structure in        a collapsed configuration after negative pressure has been        removed, the mechanism comprising one or more latching members        attached to one or more of the strips of the stabilizing        structure, the latching members configured to latch onto an        adjacent strip when the stabilizing structure moves to a        collapsed configuration.

In certain embodiments, the one or more latching members comprise alatching element that latches to said adjacent strip. The latchingelement can comprise multiple teeth, each of the teeth configured tolatch onto said adjacent strip when the stabilizing structure is in adifferent collapsed or compressed position. The latching element may bedisposed at an intermediate position along an elongate member of thelatching member, the latching element configured to pass through anopening in said adjacent strip to latch the latching member to saidadjacent strip. In certain embodiments, the device may comprise arelease mechanism comprising an arch portion interconnecting adjacentlatching members, the arch portion configured to receive a force thereonto lift the latching members from engagement with said adjacent strip ofthe stabilizing structure.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure, the stabilizing structure comprising:        -   a plurality of elongate strips; and        -   a plurality of intervening members connecting the elongate            strips, wherein the plurality of intervening members are            configured to pivot relative to the strips to allow the            plurality of elongate strips to collapse relative to one            another; and    -   a mechanism configured to maintain the stabilizing structure in        a collapsed configuration after negative pressure has been        removed, the mechanism comprising one or more first latching        members attached to one or more of the strips of the stabilizing        structure and one or more second latching members attached to        one or more of the intervening members of the stabilizing        structure, the first latching members configured to contact the        second latching members when the stabilizing structure moves to        the collapsed configuration.

In some embodiments, he first latching members may extend at anon-perpendicular angle relative to their corresponding strips and thesecond latching members can extend at a non-perpendicular angle relativeto their corresponding intervening members.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure; and    -   a support structure attached to the stabilizing structure, the        support structure configured to at least partially prevent the        collapse of the stabilizing structure.

In certain embodiments, the support structure is sized to prevent thecollapse of the entire stabilizing structure. The support structure maybe sized to prevent the collapse of a portion of the stabilizingstructure, while another portion of the stabilizing structure collapseswhen under negative pressure.

In some embodiments, the support structure comprises:

-   -   a plurality of support elements attachable to each other and        configured to extend along a plane adjacent a top or bottom end        of the stabilizing structure when attached thereto; and    -   a plurality of inserts configured to extend into the stabilizing        structure and bear against one or more surfaces of the        stabilizing structure to at least partially prevent the collapse        of the stabilizing structure.

Each of the support elements may comprise one or more frangible jointportions configured to allow a size of the support element to theadjusted. In certain embodiments, the support structure may comprise:

-   -   a plurality of support elements configured to extend along a        plane adjacent a top or bottom end of the stabilizing structure        when attached thereto, each of the support elements having a        plurality of inserts configured to extend into the stabilizing        structure and bear against one or more surfaces of the        stabilizing structure to at least partially prevent the collapse        of the stabilizing structure,    -   wherein the plurality of inserts are expandable via introduction        of a fluid into the support structure.

Each of the support elements can comprise one or more seals configuredto fluidly isolate a portion of the support structure from anotherportion of the support structure to allow adjustment in a size of thesupport structure.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure; and    -   a support structure attached to the stabilizing structure, the        support structure comprising:        -   a plurality of substantially rigid support elements            attachable to each other and configured to extend along a            plane adjacent a top or bottom end of the stabilizing            structure when attached thereto, and        -   a plurality of inserts configured to extend into the            stabilizing structure        -   and bear against one or more surfaces of the stabilizing            structure, wherein the support structure is configured to at            least partially prevent the collapse of the stabilizing            structure.

In certain embodiments, each of the support elements comprises one ormore frangible joint portions configured to allow a size of the supportelement to the adjusted.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure; and    -   a support structure attached to the stabilizing structure, the        support structure comprising:        -   a plurality of support elements configured to extend along a            plane adjacent a top or bottom end of the stabilizing            structure when attached thereto, each of the support            elements having a plurality of inserts configured to extend            into the stabilizing structure and bear against one or more            surfaces of the stabilizing structure, the plurality of            inserts being expandable via introduction of a fluid into            the support structure,        -   wherein the support structure is configured to at least            partially prevent the collapse of the stabilizing structure.

In some embodiments, each of the support elements may comprise one ormore seals configured to fluidly isolate a portion of the supportstructure from another portion of the support structure to allowadjustment in a size of the support structure.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure, wherein the stabilizing structure comprises a        plurality of cells defining a plurality of internal surfaces;        and    -   a porous layer, channels or grooves attached to at least some of        the internal surfaces, such that removal of a portion of the        stabilizing structure to size it for placement into a wound        results in the structure having an outer perimeter including at        least a portion thereof covered with the porous layer, channels        or grooves.

The stabilizing structure may comprise a plurality of cells providedside-by-side, each cell defined by one or more vertical walls, each cellhaving a top end and a bottom end with an opening extending through thetop and bottom ends, and wherein the porous layer, channels or groovesare attached to at least one or more of the vertical walls. A foam layermay be attached to at least some of the internal surfaces. An elastomerlayer may be attached to at least some of the internal surfaces. Thewound therapy device may further comprise a porous layer, channels orgrooves attached to at least a portion of an outer perimeter of thestabilizing structure.

In another embodiment, a method of treating a wound comprises:

-   -   providing a stabilizing structure, the stabilizing structure        defining an initial outer perimeter and having internal surfaces        at least partially covered by a porous layer, channels or        grooves; and    -   sizing the stabilizing structure to a desired dimension, wherein        after sizing the stabilizing structure has a final outer        perimeter that includes the internal surfaces covered by the        porous layer, channels or grooves.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure, wherein the stabilizing structure comprises a        plurality of cells defining a plurality of internal surfaces;        and    -   a porous layer, channels or grooves attached to or within at        least a portion of some of the internal surfaces, such that        removal of a portion of the stabilizing structure to size it for        placement into a wound results in the structure having either:        -   an outer perimeter including at least a portion thereof            covered with the porous layer, channels or grooves;        -   one or more internal surfaces of the cells including at            least a portion thereof covered with the porous layer,            channels or grooves; or        -   both the one or more internal surfaces of the cells and            outer perimeter including at least a portion thereof covered            with the porous layer, channels or grooves.

The stabilizing structure may comprise a plurality of cells providedside-by-side, each cell defined by one or more vertical walls, each cellhaving a top end and a bottom end with an opening extending through thetop and bottom ends, and wherein the porous layer, channels or groovesare attached to at least one or more of the vertical walls. A foam layermay be attached to at least some of the internal surfaces. In someembodiments, a wicking or acquisition distribution layer (ADL) can beattached to at least some of the internal surfaces. An elastomer layermay be attached to at least some of the internal surfaces. In certainembodiments, the device may further comprise a porous layer, channels orgrooves attached to at least a portion of an outer perimeter of thestabilizing structure. In one embodiment, the porous layer, channels orgrooves extend generally vertically between a bottom end of the cell anda top end of the cell. The porous layer, channel or grooves areconfigured to guide fluid therethrough (e.g., act as a conduit forfluid, such as wound exudate).

In one embodiment, the porous layer, channels or grooves can be disposedon at least a portion of one internal surface of the one or more cellsof the stabilizing structure. For example, in an embodiment of astabilizing structure that comprises cells that can be considered toinclude four quadrants, the porous layer, channels or grooves aredisposed on or in one quadrant of the cell. In one embodiment, theporous layer, channels or grooves are disposed so as to not restrictmovement of the one or more walls of the cell as the cell collapses whenthe stabilizing structure moves to a collapsed position, such as duringthe application of negative pressure thereto. For example, where thecell is defined by two strips and two intervening members, the porouslayer, channels or grooves can be disposed on a surface of anintervening member or a strip that defines an obtuse angle as the cellcollapses, thereby avoiding restricting the collapsing movement of thecell.

In one embodiment, the porous layer, channels or grooves can be disposedon medially-facing surfaces of the one or more cells of the stabilizingstructure, such that when the size of the stabilizing structure isadjusted (e.g., by cutting one or more strips and/or interveningmembers) to better fit the wound site, the laterally-facing surfaces ofthe one or more cells of the stabilizing structure can have asubstantially flat or planar, and in some embodiments smooth, surface.In one embodiment, anchoring members (e.g., an anchoring layer) can beattached to said laterally-facing surfaces after the size of thestabilizing structure has been adjusted.

In another embodiment, a wound closure device for negative pressurewound therapy comprises:

-   -   a stabilizing structure configured to collapse under negative        pressure, wherein the stabilizing structure comprises a        plurality of cells, each of the cells defined by one or more        vertical walls with a medial surface and a lateral surface; and    -   a porous layer, channels or grooves disposed on at least a        portion of the medial surface, such that removal of a portion of        the stabilizing structure to size it for placement into a wound        results in the structure still retaining one or more medial        surfaces with said porous layer, channels or grooves in the        resized stabilizing structure.

In some embodiments, the porous layer, channels or grooves may bedisposed on at least a portion of the medial surface such that theporous layer, channels or grooves do not restrict movement of the cellstoward a collapsed position when the stabilizing structure collapsesunder negative pressure. The one or more vertical walls may comprise ahydrophilic material. In certain embodiments, the device can furthercomprise one or more anchors disposed on at least a portion of thelateral surface, such that removal of the portion of the stabilizingstructure to size it for placement into a wound results in the structurestill retaining one or more lateral surfaces with said one or moreanchors in the resized stabilizing structure.

In another embodiment, a method of treating a wound comprises:

-   -   providing a stabilizing structure, the stabilizing structure        defining an initial outer perimeter and comprising a plurality        of cells having medial and lateral internal surfaces, wherein at        least some of the internal surfaces are at least partially        covered by a porous layer, channels or grooves; and    -   sizing the stabilizing structure to a desired dimension, wherein        after sizing the stabilizing structure includes cells having        internal surfaces covered by the porous layer, channels or        grooves.

In another embodiment, a porous pad for the treatment of wounds usingnegative pressure comprises:

-   -   a porous material suitable for channeling wound exudate from a        wound site and negative pressure to the wound site;    -   a plurality of stabilizing structures at least partially        embedded within the porous material comprising a plurality of        cells provided side-by-side in a plane, wherein the stabilizing        structures are configured to collapse more within the plane than        along the direction perpendicular to the plane; and    -   wherein the pad is dimensioned to have a generally planar shape        with a thickness less than the width and length, wherein the pad        comprises at least one cut or perforation extending through at        least a portion of the thickness of the pad dividing the pad        into a plurality of regions at least of two of which contain a        stabilizing structure, wherein at least one of the regions is        detachable, the cut or perforation defining a pad section        detachable from the pad to modify the size of the pad.

In some embodiments, the pad may comprise an open-celled foam. The padcan comprise a polyurethane foam. In some embodiments, the foam may behydrophobic, hydrophilic, open-celled, close-celled, mixed open andclose-celled, and/or reticulated. Certain embodiments may call for thefoam to comprise polyvinyl alcohol, polyurethane, polyester, silicone,and/or other suitable materials. The pad may comprise at least twoarcuate cuts or perforations extending along the pad length, and atleast two arcuate cuts or perforations extending along the pad width. Insome embodiments, the pad can comprise a plurality of outer cuts orperforations having an elliptical shape and a plurality of inner cuts orperforations having a similar elliptical shape. In certain embodiments,the porous pad further comprises a plurality of intermediate cuts orperforations between the outer cuts and the inner cuts or perforations,at least some of the intermediate cuts or perforations extendinggenerally lengthwise across the pad and at least some of theintermediate cuts or perforations extending generally widthwise acrossthe pad. The pad may comprise a plurality of concentric cuts orperforations.

In certain embodiments, the pad may comprise a three-dimensionalstructure having a plurality of cuts or perforations in the x, y and zdimensions. In certain embodiments, the pad may comprise at least twostabilizing structures spaced along the height of the pad. In someembodiments, the stabilizing structures can be constructed from amaterial selected from the group consisting of silicone, polyurethanes,flexible plastics, rigid plastics, and foam. In some embodiments, thecells of the one or more stabilizing structures may comprise a pluralityof sizes. Alternatively, all of the cells of the stabilizing structuresare identical. In some cases, one or more of the cells may bedifferently shaped from other cells. In certain embodiments, the shapeof each cell may be selected from the group consisting of square,diamond, oblong, oval, and parallelepiped.

In some embodiments, the one or more stabilizing structures areconfigured to collapse in a plurality of directions. The porous pad maycomprise at least one stabilizing structure comprising a plurality ofplanar support structures connected by spring elements. The porous padcan comprise at least one stabilizing structure having cells defined byone or more walls, each cell having a top end and a bottom end with anopening extending through the top and bottom ends in the directionperpendicular to the plane. The porous pad may comprise at least onestabilizing structure comprising a plurality of elongate stripsextending in a first direction. The porous pad can further comprise aplurality of intersecting strips extending in a second directionperpendicular to the first direction, wherein the structure iscollapsible in the first and second directions. The porous pad mayfurther comprise a plurality of intervening members connecting theelongate strips, wherein the plurality of intervening members areconfigured to pivot relative to the strips to allow the plurality ofelongate strips to collapse relative to one another. In certainembodiments, the stabilizing structures are completely encased by theporous material. In some embodiments, the pad is surrounded by aflexible anchoring layer. The plurality of stabilizing structures may becompletely separated from each other. In certain embodiments, at leastsome of the stabilizing structures are connected to each other across atleast two regions of the pad, wherein the stabilizing structures areseparable from each other.

In another embodiment, a negative pressure wound treatment system,comprises:

-   -   a porous pad as described herein this section or elsewhere in        the specification;    -   a drape sized and configured to be placed over the porous pad        and to form a substantially fluid-tight seal against a region of        skin surrounding the wound; and    -   a port configured to connect the drape to a source of negative        pressure.

Some embodiments of the system may call for the addition of a source ofnegative pressure configured to be in fluid communication with thewound.

In another embodiment, a method of treating a wound comprises;

-   -   providing a porous pad as described herein this section or        elsewhere in the specification;    -   removing portions of the porous pad to shape the pad into a        desired shape;    -   placing the porous pad into a wound;    -   covering the porous pad with a wound cover or drape; and    -   applying negative pressure to the wound via a source of negative        pressure.

In another embodiment, a method of manufacture of a porous pad comprisesthe steps of:

-   -   providing a body of a porous material comprising a stabilizing        structure configured to collapse substantially more in a first        direction than a second direction; and,    -   forming at least one partial pre-cut in a first orientation in        said body, said at least one partial pre-cut severing regions of        the body to leave detachable regions of the body, the frangible        regions allowing the portions to be selectively removed from the        body.

The partial pre-cuts may be formed by die cutting. The die cutting mayinvolve providing a plurality of blades in a suitable arrangement toprovide the desired partial pre-cuts and tearable regions.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be apparentfrom the following detailed description of the invention, taken inconjunction with the accompanying drawings of which:

FIG. 1 illustrates an embodiment of a negative pressure treatmentsystem.

FIGS. 2A-F illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 2G-2I illustrate multiple views of another embodiment of astabilizing structure.

FIG. 3 illustrates an embodiment of a ring that can surround astabilizing structure.

FIG. 4 illustrates an embodiment of a stabilizing structure withsurrounding anchoring and foam layers.

FIGS. 5A-D illustrate another embodiment of a stabilizing structure withsurrounding anchoring and foam layers.

FIG. 6 illustrates an embodiment of an open abdominal wound.

FIG. 7 illustrates an embodiment of a step in a method of treating awound.

FIG. 8 illustrates an embodiment of a step in a method of treating awound.

FIGS. 9A-C illustrate an embodiment of steps of a method of treating awound.

FIGS. 10A-C illustrate an embodiment of steps of a method of treating awound.

FIG. 11 illustrates an embodiment of steps of a method of treating awound.

FIGS. 12A-G illustrate an embodiment of steps of a method of treating awound.

FIGS. 13A-D illustrate embodiments of a stabilizing structures withrounded out walls.

FIG. 14A-C are a photograph and illustrations of embodiments of astabilizing structure optimized for collapse within a wound.

FIGS. 15A-E illustrate embodiments of a method for optimizing the designof a stabilizing structure.

FIG. 16 illustrates an embodiment of a stabilizing structure.

FIG. 17 illustrates an embodiment of a stabilizing structure.

FIG. 18A-C illustrates side views of embodiments of stabilizingstructures.

FIG. 19A-B illustrates embodiments of methods for the preparation ofdifferent wound filler shapes.

FIGS. 20A-C illustrate embodiments of a stabilizing structure withattachable porous and anchoring layers.

FIG. 21 illustrates an embodiment of a foam layer with fingers.

FIGS. 22A-D illustrate embodiments of a stabilizing structure withanchoring and porous layers.

FIG. 23 Illustrates an embodiment of an anchoring layer for adhering astabilizing structure to the tissues of a wound.

FIG. 24 is a schematic illustration of a system for the treatment ofabdominal wounds.

FIG. 25A illustrates a perspective view of one embodiment of a porouspad that can be used in the treatment of wounds.

FIG. 25B illustrates a top view of the porous pad of FIG. 2A.

FIG. 25C illustrates another embodiment of the porous pad that can beused in the treatment of wounds.

FIG. 26 illustrates an embodiment of a foam structure that can be usedin the treatment of wounds.

FIGS. 27A-B illustrate embodiments of stabilizing structures within aporous material.

FIG. 28 is a perspective view of one embodiment of a wound closuredevice for negative pressure wound therapy with one embodiment of astabilizing structure and support structure attached to the stabilizingstructure.

FIG. 29 is a top view of the wound closure device of FIG. 28 .

FIG. 30 is a bottom view of the wound closure device of FIG. 28 .

FIG. 31 is a cross-sectional view of the wound closure device of FIG. 28.

FIG. 32 shows a partial view of the wound closure device of FIG. 28 ,showing a portion of the support structure.

FIG. 33 is a schematic top view of another embodiment of a wound closuredevice for negative pressure wound therapy with another embodiment of astabilizing structure and support structure attached to the stabilizingstructure.

FIG. 34 is a schematic bottom view of the wound closure device of FIG.18 .

FIG. 35 is a perspective top view of the support structure of FIG. 33that attaches to the stabilizing structure.

FIG. 36 is a perspective bottom view of the support structure of FIG. 33.

FIG. 37 is a top planar view of the support structure of FIG. 33 .

FIG. 38 is a bottom planar view of the support structure of FIG. 33 .

FIG. 39 is a side elevational view of the support structure of FIG. 33 .

FIG. 40 is a schematic view of one embodiment of a stabilizing structurefor a wound closure device with a mechanism for latching the stabilizingstructure when in a collapsed configuration.

FIG. 41 is schematic view of one embodiment of a latching mechanism.

FIG. 42 is a schematic view of the latching mechanism of FIG. 41 coupledto a portion of the stabilizing structure when the stabilizing structureis in a collapsed configuration.

FIG. 43 is a schematic view of another embodiment of a latching memberof a latching mechanism.

FIG. 44 is a schematic view of another embodiment of a latching memberof a latching mechanism.

FIG. 45 is a schematic view of another embodiment of a stabilizingstructure for a wound closure device with a mechanism for latching thestabilizing structure when in a collapsed configuration.

FIG. 46 is a schematic view of one embodiment of a reset or releasemechanism for one or more latching members of a mechanism for latchingthe stabilizing structure when in a collapsed position.

FIG. 47 illustrates a portion of a stabilizing structure with a foamlayer configured to be attached to one or more walls within a cell ofthe stabilizing structure.

FIG. 48 illustrates a portion of a stabilizing structure with a foamlayer attached to internal walls of cells of a stabilizing structure.

FIG. 49A illustrates a cell of a stabilizing structure with a porouslayer, channels or grooves disposed on a portion of one or more walls ofthe cell, with the cell in a first orientation.

FIG. 49B illustrated the cell of FIG. 15A moving toward a collapsedposition.

FIG. 50 illustrates a portion of a stabilizing structure with a porouslayer, channels or grooves disposed on medial surfaces of one or morecells of the stabilizing structure.

FIG. 51 illustrates a portion of a stabilizing structure with one ormore anchoring members disposed on lateral or distal surfaces of one ormore cells of the stabilizing structure.

FIGS. 52A-F illustrate embodiments of stabilizing clips for attachmentto a stabilizing structures.

FIGS. 53A-C are photographs of embodiments of stabilizing structureswith attached stabilizing clips.

FIGS. 54A-G are photographs and illustrations of embodiments of anelliptical stabilizing structure with attached stabilizing clips.

FIGS. 55A-G illustrate embodiments of stabilizing clips with grippers.

FIGS. 56A-J illustrate embodiments of stabilizing clips for attachmentto a stabilizing structure with a step or recess at the intersection ofthe securing portion and the attachment portion.

FIGS. 57A-J illustrate embodiments of stabilizing clips for attachmentto a stabilizing structures with a foot.

FIGS. 58A-B illustrate embodiments of a stabilizing device forattachment to a stabilizing structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments disclosed in this section or elsewhere in this specificationrelate to apparatuses and methods of treating a wound with reducedpressure, including pump and wound dressing components and apparatuses.The apparatuses and components comprising the wound overlay and packingmaterials, if any, are sometimes collectively referred to in thissection or elsewhere in this specification as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis tom, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sterniotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, electricalburns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, traumaand venous ulcers or the like.

As is used in this section or elsewhere in this specification, reducedor negative pressure levels, such as −X mmHg, represent pressure levelsthat are below standard atmospheric pressure, which corresponds to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly,a negative pressure value of −X mmHg reflects absolute pressure that isX mmHg below 760 mmHg or, in other words, an absolute pressure of(760-X) mmHg. In addition, negative pressure that is “less” or “smaller”than −X mmHg corresponds to pressure that is closer to atmosphericpressure (e.g., −40 mmHg is less than −60 mmHg). Negative pressure thatis “more” or “greater” than −X mmHg corresponds to pressure that isfurther from atmospheric pressure (e.g., −80 mmHg is more than −60mmHg).

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −10 mmHg and−200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure. Thus, −200 mmHg would be about 560 mmHg inpractical terms. In some embodiments, the pressure range can be betweenabout −40 mmHg and −150 mmHg. Alternatively, a pressure range of up to−75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in otherembodiments a pressure range of below −75 mmHg can be used.Alternatively, a pressure range of over approximately −100 mmHg, or even−150 mmHg, can be supplied by the negative pressure apparatus. In someembodiments, the negative pressure range can be as small as about −20mmHg or about −25 mmHg, which may be useful to reduce fistulas. In someembodiments of wound closure devices described here, increased woundcontraction can lead to increased tissue expansion in the surroundingwound tissue. This effect may be increased by varying the force appliedto the tissue, for example by varying the negative pressure applied tothe wound over time, possibly in conjunction with increased tensileforces applied to the wound via embodiments of the wound closuredevices. In some embodiments, negative pressure may be varied over timefor example using a sinusoidal wave, square wave, and/or insynchronization with one or more patient physiological indices (e.g.,heartbeat).

Examples of such applications where additional disclosure relating tothe preceding descriptions may be found include application Ser. No.11/919,355, titled “Wound treatment apparatus and method,” filed Oct.26, 2007, published as US 2009/0306609; and U.S. Pat. No. 7,753,894,titled “Wound cleansing apparatus with stress,” issued Jul. 13, 2010.Both applications are hereby incorporated by reference in theirentirety. Other applications that may contain teachings relevant for usewith the embodiments described in this section or elsewhere in thisspecification may include application Ser. No. 12/886,088, titled“Systems And Methods For Using Negative Pressure Wound Therapy To ManageOpen Abdominal Wounds,” filed Sep. 20, 2010, published as US2011/0213287; application Ser. No. 13/092,042, titled “Wound DressingAnd Method Of Use,” filed Apr. 21, 2011, published as US 2011/0282309;and application Ser. No. 13/365,615, titled “Negative Pressure WoundClosure Device,” filed Feb. 3, 2012, published as US 2012/0209227, theentireties of each of which are hereby incorporated by reference. Stillmore applications that may contain teachings relevant for use with theembodiments described in this specification are application Ser. No.13/942,493, titled “Negative Pressure Wound Closure Device,” filed Jul.15, 2013, published as US 2014/0180225; PCT App. No. PCT/US2013/050619,filed Jul. 16, 2013 titled “Negative Pressure Wound Closure Device,”published as WO 2014/014871 A1; PCT App. No. PCT/US2013/050698, filedJul. 16, 2013 titled “Negative Pressure Wound Closure Device,” publishedas WO 2014/014922 A1; PCT App. No. PCT/IB2013/01555, titled “Devices andMethods for Treating and Closing Wounds with Negative Pressure,” filedMay 5, 2013, published as WO 2013/175309 A1; PCT App. No.PCT/US2014/025059, titled “Negative Pressure Wound Closure Device andSystems and Methods of Use in Treating Wounds with Negative Pressure,”filed Mar. 12, 2014, published as WO 2014/165275 A1; and PCT App. No.PCT/GB2014/050746, “Compressible Wound Fillers and Systems and Methodsof Use In Treating Wounds With Negative Pressure,” filed Mar. 13, 2014,published as WO 2014/140578 A1, the entireties of each of which arehereby incorporated by reference.

It will be understood that throughout this specification in someembodiments reference is made to an elongate, elongated or longitudinalstrip or strips. It is to be understood that these terms are to bebroadly construed and refer in some embodiments to an elongate materialhaving two parallel or substantially parallel faces, where incross-section a thickness of the material as measured perpendicular tothe faces is relatively smaller than a height of the material measuredparallel to the faces. While in some embodiments the strips may beconstructed from discrete lengths of material, in other embodiments thestrips may simply refer to elongate portions of an overall structurehaving two parallel or substantially parallel faces. The strips in someembodiments have a rectangular or generally rectangular-shaped faces,wherein a length of the face is longer than the height of the face. Insome embodiments, the length of the face may be more than 2 times, 4times, 6 times, 8 times or 10 times greater than the height of the face.

As used in this section or elsewhere in this specification, the term“horizontal,” when referring to a wound, indicates a direction or planegenerally parallel to the skin surrounding the wound. The term“vertical,” when referring to a wound, generally refers to a directionextending perpendicular to the horizontal plane. The term“longitudinal,” when referring to a wound, generally refers to adirection in the horizontal plane taken in a direction along which thewound is longest. The term “lateral,” when referring to a wound,generally refers to a direction in the horizontal plane perpendicular tothe longitudinal direction. The terms “horizontal,” “vertical,”“longitudinal,” and “lateral” may also be used to describe thestabilizing structures and wound closure devices described throughoutthis specification. When describing these structures or devices, theseterms should not be construed to require that the structures or devicesnecessarily be placed into a wound in a certain orientation, though incertain embodiments, it may be preferable to do so.

FIG. 1 illustrates an embodiment of a negative pressure treatment system100 that comprises a wound packer 102 inserted into a wound 101. Thewound packer 102 may comprise porous materials such as foam, and in someembodiments may comprise one or more embodiments of wound closuredevices described in further detail in this section or elsewhere in thisspecification. In some embodiments, the perimeter or top of any woundclosure device inserted into the wound 101 may also be covered with foamor other porous materials. A single drape 104 or multiple drapes may beplaced over the wound 101, and is preferably adhered or sealed to theskin on the periphery of the wound 101 so as to create a fluid-tightseal. An aperture 106 may be made through the drape 104 which can bemanually made or preformed into the drape 104 so as to provide a fluidicconnection from the wound 101 to a source of negative pressure such as apump 110. Preferably, the fluidic connection between the aperture 106and the pump 110 is made via a conduit 108. In some embodiments, theconduit 108 may comprise a RENASYS® Soft Port™, manufactured by Smith &Nephew. Of course, in some embodiments, the drape 104 may notnecessarily comprise an aperture 106, and the fluidic connection to thepump 110 may be made by placing the conduit 108 below the drape. In somewounds, particularly larger wounds, multiple conduits 108 may be used,fluidically connected via one or more apertures 106.

In some embodiments, the drape 104 may be provided with one or morecorrugations or folds. Preferably, the corrugations are aligned alongthe longitudinal axis of the wound, and as such may support closure ofthe wound by preferentially collapsing in a direction perpendicular tothe longitudinal axis of the wound. Such corrugations may aid in theapplication of contractile forces parallel to the wound surface and inthe direction of wound closure. Examples of such drapes may be found inapplication Ser. No. 12/922,118, titled “Vacuum Closure Device,” filedNov. 17, 2010 (published as US 2011/0054365), which is herebyincorporated by reference in its entirety.

In use, the wound 101 is prepared and cleaned. In some cases, such asabdominal wounds, a non- or minimally-adherent organ protection layer(not illustrated) may be applied over any exposed viscera. The woundpacker 102 is then inserted into the wound, and is covered with thedrape 104 so as to form a fluid-tight seal. A first end of the conduit108 is then placed in fluidic communication with the wound, for examplevia the aperture 106. The second end of the conduit 108 is connected tothe pump 110. The pump 110 may then be activated so as to supplynegative pressure to the wound 101 and evacuate wound exudate from thewound 101. As will be described in additional detail below and inrelation to the embodiments of the foregoing wound closure devices,negative pressure may also aid in promoting closure of the wound 101,for example by approximating opposing wound margins.

Stabilizing Structures and Wound Closure Devices of FIGS. 2A-5D

FIGS. 2A-F illustrate embodiments of a stabilizing structure 4200. Thestabilizing structure may comprise a plurality of elongate strips 4202arranged in parallel, whose longitudinal length can be aligned with thelongitudinal axis when placed in a wound. The stabilizing structure canfurther comprise a plurality of intervening members 4204 connected tothe elongate strips 4202 via joints 4206. In certain embodiments, thestabilizing structure 4200 can collapse in any manner described in thissection or elsewhere in this specification with or without theapplication of negative pressure. For example, the stabilizing structuremay collapse significantly more in one plane than in another plane. Insome embodiments, the stabilizing structure is configured to collapsemore in a horizontal plane parallel to the length and width of thestabilizing structure than in a vertical plane perpendicular to thehorizontal plane. In some embodiments, the stabilizing structure can becomprised of any materials described in this section or elsewhere inthis specification, including: flexible plastics such as silicone,polyurethane, rigid plastics such as polyvinyl chloride, semi-rigidplastics, semi-flexible plastics, biocompatible materials, compositematerials, metals, and foam.

The stabilizing structure 4200 and all stabilizing structures and woundclosure devices described in this section or elsewhere in thisspecification can collapse on a variety of timescales in a dynamicfashion. In certain embodiments, the majority of the collapse may occurwithin the first few minutes upon application of negative pressure.However, after the initial collapse, the stabilizing structure or woundclosure device may continue to collapse at a much slower rate, therebyapplying increasing longitudinal tension over a long period of time anddrawing the edges of the wound closer together. By slowly drawing thewound edges closer together over time, the stabilizing structure orwound closure device allows the surrounding healing tissue to remodelsynergistically with the closure of the device or stabilizing structure.Slow, dynamic wound closure may allow the surrounding tissue to heal atan accelerated rate, because the collapsing structure or device slowlybrings the edges of the wound closer together without stressing thenewly formed or weakened tissue too quickly.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification can placed into a wound for aperiod of time and then removed or replaced with another stabilizingstructure. For example, a stabilizing structure could be inserted into awound for a period of time, promoting closure of the wound by drawingthe edges closer together. After a period of time has passed, thestabilizing structure can be replaced by a stabilizing structure of adifferent size or collapsibility, for example a stabilizing structure ofa smaller size or decreased density. This process could be repeated overand over, thereby continuously drawing the edges of the wound togetherover time and allowing for continuing repair and remodeling of thesurrounding tissue. In certain embodiments, the stabilizing structure isconfigured to remain in the wound for at least about less than 1 hour,at least about 1 hour, at least about 2 hours, at least about 4 hours,at least about 6 hours, at least about 8 hours, at least about 12 hours,at least about 24 hours, at least about 2 days, at least about 4 days,at least about 6 days, at least about 1 week, at least about 2 weeks, atleast about 3 weeks, or more than 3 weeks.

In certain embodiments, up to 90% of the collapse of the stabilizingstructure or wound closure device may occur within the first few minutesupon application of negative pressure, while the remaining 10% of thecollapse may occur slowly over a period of many minutes, hours, days,weeks, or months. In other embodiments, up to about 80% of the collapse,up to about 70%, up to about 60%, up to about 50%, up to about 40%, upto about 30%, up to about 20%, up to about 10%, or about 0% of thecollapse will occur immediately within the first few minutes uponapplication of negative pressure while the remainder of the collapseoccurs at a much slower rate such as over the course of many minutes,hours, days weeks, or months. In other embodiments, the stabilizingstructure can collapse at a variable rate. In some embodiments, theentirety of the collapse occurs at a slowed rate, while in otherembodiments the entirety of the collapse occurs almost immediatelywithin the first few minutes. In further embodiments, the collapse canoccur at any rate and the rate can vary over time. In certainembodiments, the rate of collapse can be altered in a variable fashionby adding and/or removing portions of the structure or by controllingthe application of negative pressure and irrigant fluid.

As illustrated in the perspective view of FIG. 2A and the top view ofFIG. 2B, the intersection of the intervening members 4204 and theelongate strips 4202 may define a plurality of cells 4210. In certainembodiments, the cells 4210 may be of any of the shapes and sizesdescribed in this section or elsewhere in this specification. Forinstance, a cell may be in the shape of a square, a diamond, an oblong,an oval, and/or a parallelepiped. The joints 4206 are configured toallow the intervening members 4204 to collapse. The joints 4206 can beconfigured to allow the intervening members to collapse in any manner asdescribed in this section or elsewhere in this specification in relationto other embodiments. For example, the joints 4206 may be configured toallow or preferentially cause a first row of intervening members 4204 tocollapse in one direction, while allowing or preferentially causing anadjacent row to collapse in another direction. The elongate strips 4202may comprise alternating flexing segments 4212 and supporting segments4214. In a preferred embodiment, the flexing segments 4212 may beconstructed from a flexible or semi-flexible material such as siliconeand/or polyurethane. However, any flexible or semi-flexible material maybe suitable. The flexing segments 4212 can flex in any direction,allowing the stabilizing structure to collapse more readily in anydirection, but particularly in the horizontal plane. In a preferredembodiment, the supporting segments 4214 can be constructed from a rigidor semi-rigid material such as polyvinyl chloride (PVC). However, anyrigid or semi-rigid material may be suitable. In the embodimentillustrated, the elongate strips 4202 comprise elongate strips of afirst material such as silicone and/or polyurethane, with a plurality ofelongate inserts of a second, more rigid material 4214 embedded into thefirst material. Thus, the flexing segments 4212 are the areas in theelongate strips 4202 where the more rigid inserts are not located.

As illustrated in FIGS. 2A-D, the supporting segments 4214 may be largerthan the flexing segments 4212. In one embodiment, the supportingsegments 4214 can be approximately three times as large as the flexingsegments 4212 (such as by spanning three cells 4210). In otherembodiments, the supporting segments 4214 may be the same size as theflexing segments 4212. In further embodiments, the flexing segments 4212can be larger than the supporting segments 4214. Alternatively, thelengths and widths of the individual segments of the elongate strips4202 can be variable. For example, the height of the supporting segments4214 can be reduced, such that they do not extend from approximately thetop to approximately the bottom of the stabilizing structure 4200. Insome embodiments a smaller supporting segment could encompassapproximately half the height of the elongate strip 4202. In certainembodiments, the supporting segment 4214 could be located in the upperor in the lower portion of the elongate strip. Such embodiments may beaccomplished by utilizing an insert of a second material that has asmaller height than the height of the first material forming theelongate strip 4202.

In some embodiments, the supporting segment does not alternate with theflexing segment 4212 and instead, the elongate strips 4202 are comprisedentirely of supporting segments 4214 (e.g., a silicone strip or othermaterial with an embedded more rigid insert extending the entire lengththereof, or simply a more rigid material by itself). Alternatively, theentirety of the elongate strip 4202 can be comprised only of flexingsegments 4212 (e.g., a strip made only of silicone or other moreflexible material). The elongate strips 4202 may be manufactured from afemale mold that may further encompass the entire stabilizing structure4200. The supporting segments 4214 can be inserted into the female mold,followed by an injection of a flexible polymer such as silicone and/orpolyurethane to encase the supporting segments 4214 within the flexiblepolymer frame. The supporting segments 4214 can be inserted into themold in any desired manner or quantity, allowing for many potentialvariations of the stabilizing device.

In further embodiments, the supporting segments 4214 are insertableand/or removable from the elongate strips 4202, and may be insertedand/or removed to alter the collapsibility of the stabilizing structure4200. Supporting segments 4214 can be inserted and/or removed from thestabilizing structure 4200 after it has been placed in a wound tovariably control the collapse of the stabilizing structure 4200. In suchembodiments, the elongate strips 4202 may form pockets that are openfrom one side (e.g., from the top) to allow insertion and removal of thesupporting segments 4214.

FIGS. 2C-D illustrate in greater detail an embodiment of an individualsupporting segment 4214. The supporting member 4214 may be a flat,plate-like structure having a rectangular shape, with a length greaterthan its height, and two parallel surfaces. The supporting segment cancomprise at least one notch 4220, preferably located on the upper edgeof the supporting segment. In other embodiments, the notch or notchescan be located on the bottom or the sides of the supporting segment. Infurther embodiments, the top notch could have a corresponding bottomnotch, or the notches could be located semi-randomly on the top andbottom of the stabilizing structure. In certain embodiments, the notchcould be configured so as to allow tearing of the supporting segment ina transecting line across the supporting segment. The notch or notches4220 may advantageously provide flexibility to the structure. Thenotches 4220 may allow the stabilizing structure to flex more easily inthe horizontal plane or in the vertical plane. The notches 4220 mayfurther allow the stabilizing structure to twist in multiple planes. Thenotches 4220 may also improve fluid flow within the stabilizingstructure 4200. In some embodiments, the supporting segment does notcontain a notch and the uppermost edge is flat. The notch 4220 can belocated at other locations on the supporting segment, for example thebottom edge or the sides. The shape of the notch can be a roundedtriangle as in FIGS. 2C-D or any other similar shape.

The intervening members 4204 in some embodiments may comprise a firstmaterial 4216 with an embedded insert 4218 made of a more rigidmaterial. One embodiment of the embedded insert is illustrated in FIGS.2E-F. In certain embodiments, the insert 4218 is placed within a femalemold and a flexible polymer such as silicone and/or polyurethane isinjected around the insert to entomb the insert 4218 within a flexiblepolymer frame. The inserts 4218 can be inserted into the mold in anydesired manner or quantity, allowing for many potential variations ofthe stabilizing device. In other embodiments, the first material 4216may be in the form of a sleeve configured to receive the insert 4218.Further, the sleeve 4216 may be configured to allow for the removal ofan insert 4218, such as by providing an opening in the top of thesleeve. In a preferred embodiment, the first material 4216 isconstructed from a flexible or semi-flexible material such as siliconeand/or polyurethane. However, any flexible or semi-flexible material maybe suitable. In a preferred embodiment, the insert 4218 is constructedfrom a rigid or semi-rigid material such as polyvinyl chloride. However,any rigid or semi-rigid material may be suitable.

FIG. 2E illustrates a front view of insert 4218, while FIG. 2Fillustrates a side view of insert 4218. The insert in one embodiment maybe a flat, plate-like structure having a rectangular shape, with aheight greater than its width, and two parallel surfaces. The insert cancomprise an indent 4222. The indent is preferably located at the upperportion of the insert, however, the indent 4222 can be positioned oneither side of the insert, or on the bottom. The indent 4222 can beconfigured such that it aids in allowing fluid to flow through thestabilizing structure by providing a flow path. The indent 4222 canimprove flexibility of the stabilizing structure 4200 and be configuredto allow for a more efficient collapse of the stabilizing structure4200.

In some embodiments, the stabilizing structure 4200 of FIGS. 2A-B can beconfigured to include perforations or detachable sections that allowportions of the device to separate from the remainder of the device. Forexample, perforations may be incorporated into the joints 4206 betweenvarious cells contained within the stabilizing structure 4200, allowingfor the removal of individual rows or cells to alter the shape of thestabilizing structure 4200. In some embodiments, as described above inrelation to FIGS. 2C-D, the sections may be detached along perforationsor lines in the elongate strips corresponding to the notches 4220. Insome embodiments, the inserts 4218 may be entombed within first material4216 in a variable number of intervening members 4204 to control theshape and collapse of the stabilizing structure 4200. In otherembodiments, the inserts 4218 may be inserted directly into sleevescomprised of first material 4216 within the intervening members 4204 tocontrol the shape and collapse of the stabilizing structure 4200.

For example, the inserts 4218 can be present in at least about 5% of theintervening members, at least about 10% of the intervening members, atleast about 15% of the intervening members, at least about 20% of theintervening members, at least about 25% of the intervening members, atleast about 30% of the intervening members, at least about 35% of theintervening members, at least about 40% of the intervening members, atleast about 45% of the intervening members, at least about 50% of theintervening members, at least about 55% of the intervening members, atleast about 60% of the intervening members, at least about 65% of theintervening members, at least about 70% of the intervening members, atleast about 75% of the intervening members, at least about 80% of theintervening members, at least about 85% of the intervening members, atleast about 90% of the intervening members, at least about 95% of theintervening members, or about 100% of the intervening members.

In certain embodiments, a variable number of supporting segments 4214may be entombed within elongate strips 4202 to control thecollapsibility of the stabilizing structure 4200. In other embodiments,a variable number of supporting segments may be inserted into a pocketcontained within the elongate strips 4202 to control the collapsibilityof the stabilizing structure. For example, the supporting segments 4214can be present in at least about 5% of the total length of the elongatestrips, at least about 10%, at least about 15%, at least about 20%, atleast about 25%, at least about 30%, at least about 35%, at least about40%, at least about 45%, at least about 50%, at least about 55%, atleast about 60%, at least about 65%, at least about 70%, at least about75%, at least about 80%, at least about 85%, at least about 90%, atleast about 95%, or about 100% of the total length of the elongatestrips.

In certain embodiments, the inserts 4218 or supporting segments 4214 maybe inserted and/or removed over time to variably control the collapse ofthe stabilizing structure 4200. For example, although initially all theavailable sleeves 4216 of the stabilizing structure may contain aninsert, after the initial placement of the stabilizing structure in awound, additional inserts 4218 may be removed over time, thus causingthe stabilizing structure 4200 to collapse even further. Inserts canalso be added to the stabilizing structure after it is inserted into awound, thereby decreasing the collapsibility of the stabilizingstructure 4200. Thus, the addition and/or removal of the inserts 4216 orsupporting segments 4214 allows for variable control of the collapse ofthe stabilizing structure 4200. In similar fashion, supporting segments4214 can be inserted and removed from the elongated strips over time toprovide variable control over the collapse of the stabilizing structure4200.

In certain embodiments of the stabilizing structures described in thissection or elsewhere in this specification, such as in stabilizingstructure 4200 as described in FIG. 2A, the flexibility of varioussections of the stabilizing structure is enhanced by thinning of thatsection. For example, in certain embodiments, rather than using aflexible material for a flexing segment 4212 of elongate strip 4202,instead the flexing segment 4212 can be constructed of a similarmaterial to that used to construct supporting segment 4214. In thisembodiment, since supporting segment 4212 is thicker than flexingsegment 4212 it will not flex to the degree of flexion that may beexperienced by flexing segment 4212. In certain embodiments, the entirestabilizing structure 4200 may be constructed from a single rigid orsemi-rigid material, but made to have different rigid and flexibleportions by thinning certain areas of the stabilizing structure 4200. Infurther embodiments, the joints 4206 may be thinned to allow for greaterflexibility as compared to the surrounding sections. In certainembodiments, thinning of a section of the stabilizing structure 4200,may allow the thinner portion to be more readily detached from thestructure.

FIGS. 2G-2I illustrate another embodiment of a stabilizing structure4200 similar to the stabilizing structure described above with respectto FIGS. 2A-2F. In this and other embodiments, the stabilizing structuremay have a length L and a width W that extend parallel to a horizontalplane, and a thickness T that may extend vertically and perpendicular tothe horizontal plane. As illustrated, the length L and the width W maybe greater than the thickness T so that the stabilizing structure formsa generally planar or flat body having an upper surface 4230 and a lowersurface 4232 that may be parallel to each other. The thickness T of thestructure may be constant between the upper and lower surfaces, or itmay vary. The stabilizing structure of FIGS. 2G-2I may further comprisenotches 4242 and 4244 in both the upper surface 4230 and lower surface4232, respectively. These notches may extend through the elongate strips4202 as well as through supporting segments 4214.

The stabilizing structure of FIG. 2G may define an outer perimeter thatis general rectangular in shape, though other shapes are contemplated.In one embodiment, the stabilizing structure has a first side 4234 and asecond side 4236 opposite the first side. FIG. 2H illustrates a sideview of first side 4234. These sides 4234 and 4236 may be straight inshape and be parallel to each other. These sides also need not beparallel, and can have other shapes such as curved. The stabilizingstructure may also have a third side 4238 and a fourth side 4240opposite the third side. FIG. 2I illustrates a side view of third side4238. The third and fourth sides may have a zig-zag shape as shown, butmay also have other shapes such as straight and curved.

Applicable to all stabilizing structures or wound closure devicesdescribed in this section or elsewhere in the specification, a softpolymer could be molded over the entire stabilizing structure 4200 tosoften the feel of the device, thereby protecting the surrounding organsand/or other tissues. In other embodiments, the soft polymer could bemolded only over the bottom portion of the stabilizing device 4200,while in some embodiments the softer polymer can be molded over the topand/or the sides of the device. In some embodiments, the soft polymercould be molded over particular edges of the stabilizing structure 4200,such as those on the bottom, sides, and/or top. In certain embodiments,the soft polymer could be molded over any side or combination of sidesof the stabilizing structure 4200. The soft polymer may act like asoftened rim surrounding the hard edges of the stabilizing structure4200.

Applicable to all stabilizing structures or wound closure devicesdescribed in this section or elsewhere in the specification, thestabilizing structure or wound closure device may be tearable such thatthe stabilizing structure may be shaped into the shape of a wound. Insome embodiments the stabilizing structure may be tom at theintersections between intervening members and elongate strips, while infurther embodiments, the elongate strips or intervening members may betom at any suitable position.

FIG. 3 illustrates an embodiment of an anchoring layer 4800 that maysurround the stabilizing structures as described in this section orelsewhere in this specification. The ring 4800 can comprise a layer oftissue anchors 4802 configured to grip the surrounding edges of a wound.For example, the tissue anchors can be hooks, barbs, prongs, or otherstructures that serve to attach to the tissue of a wound. In certainembodiments, the tissue anchors comprise hook and loop fasteners such asthose used in Velcro technologies. In certain embodiments, the ring 4800can be comprised of foam, such as those described previously or the ringcan be comprised of a combination of a foam layer and a tissue anchorlayer 4802. A lip 4804 may extend inward from the ring 4800 and serve tooverlap the top and/or the bottom of a stabilizing structure asdescribed in this section or elsewhere in this specification, therebysecuring the ring 4800 around the stabilizing structure.

FIG. 4 is a photograph of a wound closure device 4900 comprising astabilizing structure 4902 such as those described in this section orelsewhere in this specification, a foam layer 4904 such as thosedescribed in this section or elsewhere in this specification, and ananchoring layer 4906 comprising tissue anchors similar to the ringdepicted in FIG. 3 . In some embodiments, the wound closure device 4900may be placed in a wound and sealed with a drape. Similar to theembodiments illustrated in FIGS. 2A-F, the stabilizing structure 4902can collapse in any manner described in this section or elsewhere inthis specification.

The stabilizing structures and/or wound closure devices described inthis section or elsewhere in this specification may be used inconjunction with methods or systems for the closure of a wound. In someembodiments of methods of use for closure of a wound, one or more of thestabilizing structures or wound closure devices of any of theembodiments described in this section or elsewhere in this specificationis placed into a wound. In some embodiments, an organ protection layermay be provided in the wound before placement of the stabilizingstructure. In certain embodiments, foam or other porous material may beplaced in the wound along with the stabilizing structure or woundclosure device, either below, above, or surrounding the stabilizingstructure or wound closure device. Foam or other porous material mayalso surround the perimeter of the stabilizing structure or woundclosure device. The stabilizing structure or wound closure device may beconfigured to collapse in any manner as described in this section orelsewhere in this specification, for example by having a particular sizeand shape, or by comprising a certain volume of foam or other porousmaterial within the cells of the structure. The stabilizing structure orwound closure device may further be altered in any manner described inthis section or elsewhere in this specification so as to betteraccommodate the shape of the wound. After placement in the wound, thestabilizing structure or wound closure device can be sealed by afluid-tight drape. The fluid-tight drape can comprise a port configuredfor the application of negative pressure. A source of negative pressuremay then be connected to the port and negative pressure may be appliedto the wound. The stabilizing structure or wound closure device may bereplaced over time by stabilizing structures or wound closure devices ofvarious shapes and sizes as desired to best promote wound healing.

FIGS. 5A-D are photographs of a wound closure device 5000 according toanother embodiment. The wound closure device 5000 comprises astabilizing structure 5002 which may be similar to the structuresdescribed in FIGS. 2A-I, or may comprise any of the stabilizingstructures described elsewhere in this specification. The stabilizingstructure 5002 is surrounded by a porous layer 5004 such as a layer offoam, and the porous layer is surrounded by an anchoring layer 5006comprising tissue anchors such as those anchors produced by Velcroindustries, various barbs and/or various hooks. In some embodiments, thetissue anchors are similar to the rings depicted in FIGS. 3-4 . Incertain embodiments, the porous layer may be in the form of a ribbon.The stabilizing structure 5002, porous layer 5004 and anchoring layer5006 may be provided as separate components to be attached by thepractitioner in use, or they may be pre-attached to each other.

Similar to the embodiments illustrated in FIGS. 2A-I, the stabilizingstructure 5002 can collapse in any manner described elsewhere in thisspecification, for example, horizontally. When the wound closure device5000 is implanted, the surrounding tissues can be pressed against thetissue anchors to embed them within the tissue and anchor the device. Insome embodiments, the wound closure device 5000 may be placed in a woundand sealed with a drape. Although the embodiments further described inthis section comprise an anchor layer that surrounds a porous layer,other embodiments may omit the porous layer, such that the anchoringlayer directly surrounds or is attached to the stabilizing structure.

In some embodiments, the anchoring layer 5006 comprises an elongatestrip of material comprising a plurality of tissue anchors extendingfrom a base layer 5007, wherein the tissue anchors can have differentshapes and sizes as described elsewhere in the specification. The tissueanchors may extend from a first planar side of the elongate strip, andthe second planar side of the elongate strip may comprise an adhesivecovered by an adhesive backing layer. The structure of the anchors canhave various forms depending on the tissue they are intended to bind.Longer anchors can be used for loosely bound tissues such as fat orconnective tissue, while shorter anchors can be used for denser tissuessuch as muscle. In other embodiments, depending upon the shape of theanchor, shorter anchors may be more desirable for softer, fatty tissue,while longer anchors are utilized for denser tissues. Anchors with morerigid stems can be utilized to penetrate denser tissues. In someembodiments, anchors can have bilateral prongs that tend to collapseupon insertion in tissue and yet expand when pulled in an oppositedirection such that a certain pulling force can be applied to tissue.The characteristics of the anchors or attachment mechanisms, and theirresulting force profiles, can vary by a number of parameters, such asthe length of the anchor, the shape of the attachment mechanisms, thestructure of grasping features, the material(s) used for the attachmentmechanisms, the relative flexibility/rigidity of the attachmentmechanisms, and the spacing/density of the attachment mechanisms.

The anchors may have various lengths for optimal penetration of thesurrounding tissue. For example, the length of the anchors may be atmost about 0.01 mm, at most about 0.1 mm, at most about 0.2 mm, at mostabout 0.5 mm, at most about 1 mm, at most about 2 mm, at most about 3mm, at most about 5 mm, at most about 10 mm, at most about 20 mm, atmost about 30 mm, at most about 40 mm, at most about 50 mm, at mostabout 75 mm, at most about 100 mm, or more than 100 mm.

FIG. 5B is a photograph of a closer view of the anchoring layer 5006 ofthe wound closure device 5002 depicted in FIG. 5A. The anchoring layermay consist of a first band of longer anchors 5008 configured tosurround the porous layer 5004 and stabilizing structure 5002, and asecond band of shorter anchors 5010 configured to surround the porouslayer 5004 and stabilizing structure 5002. As illustrated, the firstband 5008 may be disposed above the second band 5010. In someembodiments, there may be additional alternating series of bandsvertically relative to each other. In further embodiments, the differentbands may have different anchor lengths and shapes, as disclosed hereinthis section and elsewhere in the specification. For example, instead of2 types of bands with 2 types of anchors, there may be 3 types of bandwith 3 types of anchors or 4 types of bands with 4 types of anchors andso on. Preferably, the anchors are selected for the appropriate tissuetypes. For example, returning to FIG. 5B, the first band 5008 maycomprise longer anchors, desirable for penetration into the denserfascia, and thus may be positioned towards the bottom of the device.Similarly, the second band 5010 comprises shorter double hooks,desirable for penetration into denser tissue. Other suitable tissueanchors, as described elsewhere in this specification, include the hookand loop configuration of Velcro, barbs, hooks, spikes, pegs,arrowheads, or any suitable shape. Further examples of surfaces includetextured surfaces, such as roughened sandpaper-like surfaces, ornano-textured surfaces that may facilitate tissue adhesion.

In some embodiments, the use of surface anchors can be used incombination with a surgical adhesive, providing a much stronger bondbetween tissue layers than the adhesive alone, and providing temporaryadhesion while the adhesive sets. In some embodiments, the surgicaladhesive can be added to the anchors themselves. In certain embodiments,the surgical adhesive may simply be applied between the anchors to coatat least a portion of the anchoring layer. In further embodiments, theanchors may be replaced with a surgical adhesive, and the surgicaladhesive may act to anchor the device to the surrounding wound.

In certain embodiments, the anchors may be constructed from a variety ofmaterials, including any materials disclosed elsewhere in thespecification, such as: synthetic or natural polymers, metals, ceramics,or other suitable materials. The anchors may be constructed frombiodegradable materials such as biodegradable synthetic or naturalpolymers. Non-limiting examples of biodegradable synthetic polymersinclude: polyesters such as polylactic acid or polyglycolic acid,polyanhydrides, and linear polymers with biodegradable linkages.Further, the anchors may be constructed of biodegradable biologicalmaterials, such as autografts, allografts, and/or xenografts.

FIG. 5C is a photograph of an embodiment of a wound closure device 5000,similar to the wound closure devices of FIGS. 5A-B. However, in thisorientation the first band 5008 of anchors is towards the bottom of thedevice, while the second band of anchors 5010 is towards the top. Asdescribed above, the bands of anchors may be arrayed in any desiredmanner. FIG. 5D is a top view of an embodiment of a wound closure device5000, similar to the wound closure devices of FIGS. 5A-C.

Considering the anchoring layer of FIGS. 5A-D, the shape of theanchoring layer is not limited to the ring shape of FIGS. 4-5D. In someembodiments, the anchoring layer is wrapped around the entirety of thestabilizing device, i.e. the top, bottom, and sides. In otherembodiments, the anchoring layer is only around a portion of theperimeter of the stabilizing structure. In certain embodiments, theanchoring layer is only attached to discrete portions of the stabilizingstructure as needed. In some embodiments, the anchoring layer covers atmost about 5%, at most about 10%, at most about 20%, at most about 30%,at most about 50%, at most about 75%, and at most about 100% of theoutside of the stabilizing structure.

In some embodiments, the bands of different tissue anchors can beorganized in a vertical direction, while in other embodiments, they maybe organized in a horizontal direction. They may also be organized ineither the horizontal and vertical directions when considered in the xyplane, i.e. facing downward into the wound.

In certain embodiments, the different types of anchors may beinterspersed with one another, rather than organized into discrete bandsof specific types of anchors. For example, the longer anchors may besurrounded by smaller anchors and vice-versa. In some embodiments, theanchors may be organized randomly across the anchoring layer or in othersuitable patterns.

In particular embodiments, the anchoring layer may be disposed on theinner faces of the stabilizing structure. For example, the anchoringlayer may cover at most about 5%, at most about 10%, at most about 20%,at most about 30%, at most about 50%, at most about 75%, and at mostabout 100% of the interior surfaces of the stabilizing structure.

In further embodiments, the entire anchoring layer may be comprised ofonly one type of anchor, for example the entirety of the anchoring layermay be comprised of the longer hooks 5008 or the shorter hooks 5010 asdepicted in FIG. 5B. Some embodiments may call for the anchors to becolor coded. For example, the anchors on the bottom may be made to beone color while the anchors on the top may be another so as to identifythe proper orientation of the stabilizing structure in the wound.

Wound Closure and Treatment Methods of FIGS. 6-12G

FIGS. 6-10D are photographs and illustrations depicting embodiments of amethod for the treatment of a wound that utilizes a wound closure devicecomprising a stabilizing structure as described herein this section andelsewhere in the specification. To better illustrate a non-limitingembodiment of the method, numbers have been added to each step in FIGS.10A-D to allow the reader to more easily follow these steps of themethod. However, the steps can be performed in any order, and anynumbering system is for clarity only. Further, in some embodiments,different steps of this method may be excluded. In other embodiments,additional steps may be added to the method based on methods describedherein this section and elsewhere in the specification. The porouslayers and structures described in this section may be of any materialor structure described elsewhere in the specification, such as foam.

FIG. 6 depicts an embodiment of an open wound 5100 prior to treatmentwith a wound closure device as will be described in much greater detailbelow. The open wound of FIG. 6 is similar to the wounds describedelsewhere in the specification, particularly as relates to FIG. 1 . Insome instances, as described elsewhere in the specification, such awound may be produced via a surgical incision or other means.

FIG. 7 depicts an embodiment of an initial step in a method for thetreatment of an open wound 5100 with a wound closure device. Beforetreatment, the wound may be cleaned with a pad 5180 and the skin 5190prepared for application of a wound closure device, such as thosedescribed in relation to FIGS. 2A-5D and FIGS. 10A-10C.

FIG. 8 depicts an embodiment of an early step in a method for thetreatment of an open wound 5100. In some embodiments, a tissueprotection layer 5170 may be placed over the wound to protect theunderlying tissues from the rigors of negative pressure wound therapy orother potential harms. Accordingly, certain embodiments provide for atissue protection layer 5170 which may be cut to size to be placed overthe wound site 5100. The tissue protection layer 5170 can be a materialwhich will not adhere to the wound site or to the exposed viscera inclose proximity. Such a tissue protection layer may be constructed fromany suitable material such as a biocompatible polymer. For example,organ protection layers manufactured by Smith & Nephew and sold underthe brand RENASYS® may act as tissue protection layers and be placedover the abdominal cavity and/or wound bed 5100 and tucked over theperitoneal gutter. In further examples, materials such as thefluoroplymer polytetrafluoroethylene (PTFE) may be applicable as thesematerials are generally non-adherent and used in surgical grafts. In oneembodiment, the tissue protection layer is permeable. For example, thetissue protection layer 5170 can be provided with openings, such asholes, slits, or channels, to allow the removal of fluids from the woundsite 5100 or the transmittal of negative pressure to the wound site5100. In further embodiments, the tissue protection layer may be usedover non-abdominal wounds on other areas of the body, such as the leg,arm, shoulder, or back. In certain embodiments, the tissue protectionlayer may comprise a sensor configured to measure pressures in andaround the wound. For example, the sensor may be used to measure thelevel of negative pressure applied to the wound or to measure thepressure on the underlying organs beneath the abdominal wound.

FIGS. 9A-C illustrate embodiments of possible initial steps in a methodfor the treatment of an open wound. However, as described above, thesteps need not be performed in this order and may be performed in anyorder. In FIG. 9A, two pieces of a porous material such as foam, abottom piece 5102 and a top piece 5116 are selected so as to approximatethe size of the wound 5100. In some embodiments, the top piece and thebottom piece are of identical thickness. However, in certainembodiments, and vice-versa, top piece 5116 may be at least twice asthick, at least four times as thick, at least 10 times as thick or morethan ten times as thick as bottom piece 5102. FIG. 9B illustrates anembodiment of additional steps in a method for the treatment of an openwound. Bottom piece 5102 may be shaped via cutting or other suitablemeans to the shape of the wound and subsequently placed into the wound5100, as shown in FIG. 9C and depicted further below in FIG. 10A.

Beginning with steps 1 and 2 of FIG. 10A, after shaping, a foam layer5102 (for example, a 15 mm layer of foam) is placed in the wound bed5100. In steps 3-4, a stabilizing structure 5104 similar to thestabilizing structures disclosed in FIGS. 2A-I or any other stabilizingstructure described elsewhere in the specification, is shaped to thesize of the wound via cutting or other suitable means. In certainembodiments, the matrix may be shaped in such a manner as to ensure thatthe matrix has flat, longitudinal sides. As displayed in step 4, thestabilizing structure 5104 may be placed in the wound to determine theaccuracy of the shaping step. Preferably, when using a stabilizingstructure of FIGS. 2A-I, the stabilizing structure is placed such thatgrooves or notches as described elsewhere in the specification arefacing downward. However, in some embodiments, grooves or notches may bepresent on both the top and the bottom of the stabilizing structure. Insteps 5-6 of FIG. 10B, a foam layer 5106, in the shape of a ribbon, isattached to the outer edge of the stabilizing structure 5104 via anadhesive backing tape or other suitable means. The foam layer 5106 maybe used to partially or completely surround the perimeter of thestabilizing structure 5104. Excess ribbon can simply be removed from thebacking tape and discarded. To allow the backing layer to properlyadhere to the stabilizing structure, the foam layer may be held in placefor an excess of 30 seconds.

Step 7 of FIG. 10B shows the next step of an embodiment of the method,wherein an anchoring layer 5108 comprising a first band of longeranchors 5110 and a second band of shorter anchors 5112 is attached tothe foam layer 5106. The anchoring layer 5108 may be shaped to the sizeof the perimeter of the stabilizing structure 5104 and adhered to thefoam layer 5106 via the removal of an adhesive backing layer covering anadhesive surface on a side of the elongate layer opposite the anchors.The anchoring layer may partially or completely surround the foam layer.To allow the anchoring layer to properly adhere to the stabilizingstructure, the anchoring layer may be held in place for a period oftime, for example in excess of 30 seconds. Once the anchoring layer hasbeen applied to the foam layer 5106 and stabilizing structure 5104, theentire wound closure device 5114 may be placed into the wound 5100, asdisplayed in step 8 of FIG. 10B. To assist with the insertion of thedevice into the wound bed, the device can be deformed slightly inwardlyor horizontally to facilitate entrance into the wound site. In someembodiments, the device may be squeezed slightly during insertion andthen release upon contact with the walls of the wound. In certainembodiments, the wound closure device 5114 may be placed such that thelongitudinal sides of the matrix align with the longitudinal axis of thewound 5100.

In some embodiments, it may be preferable to orient the shorter secondanchors 5112 towards the top of the wound and the longer first anchors5110 towards the bottom of the wound so that the shorter anchors 5112may engage the fatty tissue of the wound. However, in other embodiments,depending on the shape of the anchors, it may be desirable to orient thecombination in the opposite orientation such that the longer anchors5110 engage the fatty tissue. The anchors may also have the same length.In certain embodiments, the anchors may be color coded, to direct a useto a particular orientation of the stabilizing structure. The anchorsalso need not cover the entire outer perimeter of the stabilizingstructure. In some embodiments, anchors are provided only on the firstside 4234 and second side 4236 of the stabilizing structure (for anembodiment such as illustrated in FIG. 2G).

FIG. 10C contains photographs of step 9 and 10 of a method of woundclosure and treatment. In step 9, another foam layer 5116 (for example,a 10 mm layer of foam) is placed on top of the wound closure device5114. As displayed in step 10, a bridging portion of foam 5118 may beplaced in intimate contact with the foam layer 5116 at the edge of thewound. The bridging portion of foam 5118 may extend over intact skin,with a piece of drape 5120 placed between it and the intact skin.Further, a suction port 5122 may be connected to the bridging portion5118 with a section of drape 5120 between. In alternative embodiments,the bridging portion 5118 and suction port 5122 may be placed on thewound during a different step, for example during steps 1 and 2 asdepicted in FIG. 10A.

In FIG. 11 , as shown by steps 11-14, the device may be covered by oneor more drapes 5120. A hole may be made in the drape covering thebridging portion of foam, and a suction port 5122 may be placed over thehole. A protective layer 5124 on the top surface of the one or moredrapes may be removed after the drapes 5120 are applied. Once the drapes5120 are applied and the port is in place, negative pressure may beapplied to the wound through the drape from a vacuum source. Thenegative pressure can cause the stabilizing structure to collapsehorizontally as described elsewhere in this specification. The tissueanchors adhered to the stabilizing structure through the porous layerengage tissue of the wound and may facilitate closure of the wound.

FIGS. 12A-12C provide further illustrations of an upper foam layer 5116being placed in a wound, followed by placing a bridging portion 5118 andplacing one or more drapes or wound covers 5120. FIGS. 12D-12Gillustrate an embodiment of several steps in a method for the treatmentand closure of a wound. As illustrated in FIG. 12D, a suction port 5122is separated from a release liner 5126 and later applied to a wound asdepicted in FIGS. 10A-11 . FIG. 12E illustrates a canister 5128 beinginserted into a negative pressure wound therapy device 5130 inpreparation for the collection of wound exudate. FIG. 12F illustratesthe snap connection between the tubing connected to the suction port andthe tubing connected to the negative pressure wound therapy device 5130.Once the connection has been made, negative pressure wound treatment maybegin as depicted in FIG. 12G.

Further details regarding the wound closure devices, stabilizingstructures, related apparatuses and methods of use that may be combinedwith or incorporated into any of the embodiments described herein arefound elsewhere throughout this specification and in InternationalApplication No. PCT/US2013/050698, filed Jul. 16, 2013, published as WO2014/014922 A1, the entirety of which is hereby incorporated byreference.

Stabilizing Structures and Wound Closure Devices of FIGS. 13A-15E

FIGS. 13A-D illustrate embodiments of a stabilizing structure 6000 thatare similar to the embodiments described above in relation to FIGS.2A-I. In contrast to the stabilizing structures disclosed in FIGS. 2A-I,stabilizing structure 6000 may have an outer perimeter 6002 that definesan at least partially elliptical shape. Similar to the stabilizingstructures of FIGS. 2A-I, stabilizing structure 6000 comprises aplurality of cells 6004 provided side-by-side, each cell defined by oneor more walls, each cell having a top end and a bottom end with anopening extending through the top and bottom ends. As with the otherstabilizing structures described herein this section and elsewhere inthe specification, the stabilizing structure 6000 is configured tocollapse by collapsing one or more cells 6004. In some embodiments, thecells are all of the same approximate shape and size; however, in otherembodiments, the cells are of different shapes and sizes. In someembodiments, the stabilizing structures as described herein this sectionor elsewhere in the specification may be domed, such that the centralportion of the stabilizing structure bulges upward. For example, a lowerportion of the stabilizing structure may be concave, while an upperportion of the stabilizing structure is convex. Further description ofsuch an embodiment is found with respect to FIGS. 18A-18C of thisspecification. The stabilizing structure 6000 comprises a plurality ofelongate strips 6006 arranged in parallel or semi-parallel, whoselongitudinal length can be aligned with the longitudinal axis of thewound. The elongate strips 6006 may also be arranged in a non-parallelfashion. These elongate strips 6006 may be of similar type to theelongate strips disclosed above in relation to FIGS. 2A-I. For example,elongate strips 6006 may comprise sections of more rigid material andsections of more flexible material as disclosed in relation to FIGS.2A-I. In some embodiments, the elongate strips 6006 are made from onesingle material. Further, elongate strips 6006 may be broken up intovarious segments 6008 to allow flexing of the elongate strips. Incertain embodiments, the elongate strips 6006 may be curved along theirlength so as to facilitate the curved outer perimeter of the stabilizingstructure 6000. The elongate strips may be curved along their lengthsoutward away from a center of the stabilizing structure 6000. The archof the curves of the elongate strips 6006 may vary considerably, withsome strips 6006 being highly curved while other are minimally curved oreven straight.

Similarly, the stabilizing structure 6000 can further comprise aplurality of intervening members 6010 connected to the elongate strips6006. The intervening members 6010 may all be of a similar shape andsize or they may be of a variety of shapes and sizes as depicted inFIGS. 13A-D. The intervening members may be similar in construction andfunction to the intervening members of FIGS. 2A-I, or they may be ofdifferent types such as of a single, solid material. In someembodiments, the intervening members 6010 that are located in-line withthe bulging section of the elliptical perimeter 6002 may be larger thanintervening members 6010 located elsewhere so as to facilitate theoutward perimeter 6002 of the ellipse.

Advantageously, such an elliptically shaped stabilizing structure mayallow the structure to better accommodate the shape of the wound. Mostwounds are in shapes that are more rounded than the square shape of thestabilizing structures depicted in FIGS. 2A-I. Thus, an ellipticallyshaped stabilizing structure 6000 may better fit into a wound.

Referring now to the stabilizing structures of FIGS. 13A-B, the outerperimeter 6002 may have a reduced edge 6012 so as to facilitate collapseof the stabilizing structure. By removing mass of the stabilizingstructure at reduced edge 6012, the stabilizing structure can collapsemore freely at reduced edge 6012, thus allowing for a better fit withinthe wound. Further, by reduced the mass at reduced edge 6012, there maybe less pinching of the surrounding tissue during and after collapse ofthe stabilizing structure 6000. FIG. 13B depicts a top view of thestabilizing structure of FIG. 13A.

FIG. 13C illustrates an embodiment of a stabilizing structure similar tothe structure described in relation to FIGS. 13A-B. However, in thiscase, some of the elongate strips 6006 may further comprise flexiblewall portions 6014 that allow the stabilizing structure 6000 to moreeasily collapse. When the various cells 6004 of the structure are ofdifferent shapes and sizes, as depicted in FIG. 13C, collapse may belimited by the length of the individual segments of the elongate strips6006. By making the strips 6006 more flexible, complete closure isfacilitated. In certain embodiments, the elongate strips 6006 canexpand, compress, lengthen, shorten, stretch, and/or tighten. In someembodiments, the flexible wall portions 6014 of the elongate strips 6006may be replaced by a flexible tube aligned perpendicularly to the planeof the stabilizing structure. In further embodiments, the flexible wallportions 2014 may comprise different materials, thinned sections, aconcertina design, a V-edge, or any other suitable design. Where thegeometry requires that the elongate strips 6006 adjust as thestabilizing structure 6000 is compressed, flexible wall portions 2014may be inserted much like the inserts described above in relation toFIGS. 2A-I. In particular embodiments, the outer elongate strips 6006may comprise flexible wall portions 6014, while the inner may not. Oneof skill in the art would understand that any suitable combination ofelongate strips 6006 with or without flexible wall portions 6014 may bepossible.

FIG. 13D illustrates an embodiment of a stabilizing structure 6000similar to the structures of FIGS. 13A-C. However, FIG. 13D depicts acombination of curved and straight elongate strips 6006 and cells 6004with a variety of shapes and sizes. Further, in some embodiments, theelongate strips 6006 may not extend for the entire length of thestabilizing structure 6000. Further, some of the elongate strips may bejoined at their ends.

FIG. 14A is a photograph of an embodiment of a stabilizing structure6000 similar to the structures of FIGS. 13A-D. As in FIGS. 13A-D, thestabilizing structure 6000 comprises a plurality of elongate strips 6006arranged in parallel or semi-parallel, whose longitudinal length can bealigned with the longitudinal axis of the wound. Similar to FIG. 13D,the various cells within this stabilizing structure 6000 may have avariety of shapes and sizes. As will be described in greater detailbelow, the length and shape of the elongate strips 6006, interveningmembers 6010, and cells 6004 may be designed so as to facilitate greaterclosure of the stabilizing structure. In certain embodiments, thejunctions 6900 between the elongate strips and intervening members maybe thinned to better facilitate rotation and closure of the stabilizingstructures. In some embodiments, the stabilizing structure is tearable,such that the structure may be shaped into the shape of a wound. Asdescribed elsewhere in the specification, tears may be completed at theintersection between intervening members and elongate strips or at anysuitable location along the elongate strip or intervening member.

In some embodiments, the pattern of the stabilizing structure isdesigned in such a way as to facilitate maximum closure of thestabilizing structure. Preferably, maximum closure is in a directionperpendicular to the length of the elongate members and within thehorizontal plane. As will be described in greater detail below, greaterclosure may be achieved by varying the length of the elongate strips6006, the length of the intervening members 6010, and the shape of thecells 6004. The shape of the cells 6004 may comprise any shape describedherein this section or elsewhere in the specification. For example, asdepicted in FIG. 14A, the cells 6004 may be diamond-shaped orparallelpiped with smaller diamond-like shapes 6020 located withinlarger diamonds 6022. Such a construction may provide greater overallclosure of the stabilizing device 6000 to provide for maximum closure ofthe wound. Additionally, the smaller diamond-like shapes 6020 locatedwithin larger diamonds 6022 can spread the load over a greater areareducing the chance of damage to the tissue structures below the matrix.This construction can also reduce the likelihood of the foam or thedrape being pulled into the matrix and preventing closure of the wound.

FIGS. 14B-C are illustrations of different views of the stabilizingstructure embodiment of FIG. 14A. As described above in relation to FIG.14A, the stabilizing structure comprises cells 6004, intervening members6010, and elongate strips 6006; however, here a simulated shape of awound 6910 is also included for comparison.

Any of the stabilizing structures described herein this section orelsewhere in the specification may be constructed from any suitablemeans. For example, the stabilizing structures may be constructed viamolding or may be printed directly using 3D printing technology. Incertain embodiments, the stabilizing structures of FIGS. 14A-C may beconstructed from a single polymer via 3D printing. In some embodiments,the stabilizing structures may be constructed from one polymer, twopolymers, three polymers, or more than three polymers. The stabilizingstructures may be constructed from any material disclosed herein thissection or elsewhere in the specification. The stabilizing structure canbe made by cutting the structure out of a solid block of material.Methods used for cutting can include, for example, waterjet cutting,laser cutting, or die cutting. The stabilizing structures may be cut tosize along the walls of the cells 6004. For example, the interveningmembers along the outside face of elongate strips 6006 can be cut off toappropriately size the stabilizing structure. The stabilizing structuremay be cut along the walls, along any portions of the elongate strips,and/or along any portions of the intervening members.

FIGS. 15A-D depict methodologies for generating the design of astabilizing structure, such as the stabilizing structures of FIGS.13A-14 . To facilitate various types of closure, for example maximumclosure, the shape, size, and location of the elongate strips,intervening members, and cells may be determined via various methods.For example, as depicted in FIG. 15A, each collapsible cell 6030 hasfour sides, and each intersection between an intervening member(s)and/or elongated strip(s) may be modeled via pin-joints 6032. Further,the entirety of stabilizing structure 6034 may be modeled inside of anoval wound model 6036. As depicted in FIG. 15A, the stabilizingstructure 6034 may be modeled to collapse from an open state 6038 to asemi-collapsed state 6040, to a fully collapsed state 6042. In someclinical scenarios, maximum closure down to a completely flattenedstabilizing structure may be desirable to maximize wound closure bydrawing the edges of the wound as close together as possible.

As illustrated in FIG. 15B, in certain embodiments, the process ofdetermining the optimal shape, size, and location of the elongatestrips, intervening members, and cells for wound closure may befacilitated by modeling the stabilizing structure as a mirrored patternon opposite sides of a mirror line 6050 (which may also be referred toas the transverse axis, perpendicular to a longitudinal axis of thestabilizing structure), thereby making the curve and collapse of thestabilizing structure symmetrical. The mirror axis may be along theminor axis or it may be along the major axis of the stabilizingstructure. Alternatively, the mirror line may be located in any suitablelocation within the stabilizing structure, such as diagonally across thestabilizing structure. In certain embodiments, this method may lead tolarge diamond-shaped cells near the center line. These largediamond-shaped structures 6052 may be further subdivided to furthersupport the stabilizing structure by including smaller diamond shapes6054 within larger shapes. In some embodiments, these smaller shapes6054 within a larger shape 6052 may comprise any shape disclosed hereinthis section or elsewhere in the specification. The larger cells may befurther subdivided by two smaller shapes, three smaller shapes, foursmaller shapes, or more than four smaller shapes. It will be understoodby one of skill in the art that the mirror line need not be confined toa line perpendicular to the longitudinal orientation of the wound.Instead, the mirror line may be located along the longitudinal axis ofthe wound or at an angle to the longitudinal axis of the wound. In someembodiments, the stabilizing structure may contain multiple mirrorlines, thereby having multiple subsections that are symmetrical ordifferent.

As illustrated in FIG. 15C, for a four-sided cell to collapse, it mustfollow a simple formula: a+b=c+d, where a, b, c, and d are the lengthsof individual sides of a single cell within the stabilizing structuresuch as the cell 6060 of FIG. 15C. When members c and b collapsetogether, then d and a collapse together.

FIG. 15D illustrates an expansion of the concept described in FIG. 15C.By using the base formula a+b=c+d, the elongate strips wereprogressively lengthened (a4>a3>a2>a1) towards the horizontal mirrorline 6032, thereby achieving a curve in the stabilizing structure whilepreventing any of the intervening members 6062 from becomingperpendicular to the elongate strips 6064 (i.e. having an internal angleof 90 degrees). As illustrated in FIG. 15D, a value for b1 may bechosen, at which point an arbitrary offset value x may also be chosen toease the construction of the various cell geometries. Using theprogressive values for a1 through a4, illustrated visually in FIG. 15D6066, values for b1-b4 may be calculated 6068. Using calculated valuesderived from equations 6068 for the various walls of the individualcells allows for the design of a stabilizing structure that collapsescompletely, such as those depicted in FIGS. 14A-B.

In some embodiments, a method for generating a stabilizing structuredesign may include steps to speed up the initial geometry construction.For example if all members from left to right in a specific row, asvisualized by intervening members 6036 in FIG. 15E, a pattern thenemerges where alternating vertical members are also the same length.Walls of the same length are indicated by their respective labels 6070,6072, 6074, and 6076. Once the initial design is generated thenindividual cells may be modified by lengthening, shortening, removing orinserted according to the formulas of FIG. 15D to achieve the desiredshape of the overall stabilizing structure.

The Elliptical and Domed Structures of FIGS. 16-18B

FIG. 16 illustrates a stabilizing structure 6000 similar to thestructures disclosed above in relation to FIGS. 13A-D. However,stabilizing structure 6000 may have a gap 6018 removed or having nomaterial. By removing mass from the stabilizing structure, thestabilizing structure may collapse more readily and fully within thewound. In further embodiments, any section of the stabilizing structuremay be removed to facilitate closure. For example, a strip of sectionsmay be removed, a side of sections, an inner portion located moreclosely to one side of the stabilizing structure, etc. Elongate stripsshown in FIG. 16 may be joined at their ends to form concentricelliptical shapes, or there may be concentric, continuous strips formedinto an elliptical or oval shape, with intervening members as describedabove in between.

FIG. 17 illustrates another stabilizing structure similar to thestructures described in relation to FIGS. 13A-14C. FIG. 17 builds on theconcept of FIG. 16 , whereas portions of the stabilizing structure areremoved to decrease the mass of the structure, thus facilitatingclosure. Reducing the mass of the stabilizing structure may proveadvantageous for wound healing because the mass of the wound may be arate-limiting step in wound closure. The stabilizing structure 6000 ofFIG. 17 may have an outer perimeter 6002 defining a bi-elliptical shape.

Here, reduced edge 6012 allows the stabilizing structure to collapsemore readily at the edges of the device to better facilitate placementinto the wound, facilitate closure of the wound, and reduce pinching atthe edges of the stabilizing structure 6000 as described above. In someembodiments, the elongate strips 6006 may be of various lengths and maybe curved or un-curved as depicted in FIG. 17 . In particularembodiments, the stabilizing structure 6000 of FIG. 17 may be cut down acenterline 6020 to allow for the creation of multiple smallerstabilizing structures. As will be understood by one of skill in theart, various shapes and sizes of stabilizing structures may be createdby this technique.

FIGS. 18A-C depict stabilizing structures 6100 similar to thestabilizing structures described herein this section or elsewhere in thespecification. However, the stabilizing structures of FIGS. 18A-C arecurved upward or downward in a perpendicular direction (e.g., a verticaldirection) to the general plane (e.g., the horizontal plane) of thestabilizing structure. As will be understood by one of skill in the art,such an upward or downward curving may be applied to any of thestabilizing structures described herein this section or elsewhere in thespecification.

A curved stabilizing structure 6100 such as the structure depicted inFIG. 18A, showing the stabilizing structure from the side, may beadvantageous for placement over all wounds, but particularly abdominalwounds. The exposed tissues 6102 of an abdominal wound, such as thebowel, have a tendency to bulge upward and outward from the body. Bybulging upward, the bowel creates a convex surface that does not alignas closely with a flattened bottom surface, such as the bottom surfacesof the stabilizing structures depicted above in FIGS. 2A-I and 13A-14C.

In some embodiments, a lower portion 6104 of the stabilizing structure6100 may be concave in a first horizontal direction and/or in a secondhorizontal direction perpendicular to the first horizontal direction. Incertain embodiments, an upper portion 6106 of the stabilizing structure6100 may be convex along at least an upper portion 6106 of thestabilizing structure 6100, for example in a first horizontal directionand/or a second horizontal direction perpendicular to the firsthorizontal direction. Accordingly, in some embodiments the stabilizingstructure has an arched or domed shape. In other embodiments, only thelower surface may be concave, and the upper surface may be flat orplanar.

Such a structure as depicted in FIG. 18A may better fit over a bulgingwound and allow for expansion of the tissue. A curved shape with aconcave bottom may further serve to relieve discomfort in a patient, asthe underlying tissues would not necessarily need to be compressed tothe degree that may be required with a flattened surface. Thus, thestabilizing structures of FIGS. 18A-B may be placed into an abdominalwound and conform to the shape of internal organs.

In certain embodiments, an upper portion 6106 of the stabilizingstructure is convex in a first horizontal direction and in a secondhorizontal direction perpendicular to the first horizontal direction.Some embodiments may call for the stabilizing structure to be pre-formedto have either or both of a concave lower surface 6104 and a convexupper surface 6106. However, any combination of concave, convex and flatsurfaces may be possible.

In certain embodiments, the top 6106 and/or bottom 6104 portion of thestabilizing structure may be concave/convex while the corresponding top6106 or bottom 6104 may be flat. Such a design may have a variablethickness over the length of the stabilizing structure 6100.

FIGS. 18B-C illustrate side views of curved stabilizing structuressimilar to the structure described above in relation to FIG. 18A. Insome embodiments, the stabilizing structures may have a shape similar toa contact lens, essentially acting like a bowl. In some embodiments, thebottom portion 6104 may be concave as depicted in FIG. 18B, or it may beconvex as depicted in FIG. 18C. One of skill in the art will understandthat any combination of convexity and concavity on the top and bottomsurfaces may be possible.

FIGS. 19A-B depict embodiments of modifiable stabilizing structuresand/or wound closure devices 6200, similar to the stabilizing structuresand wound closure devices described elsewhere in the specification,particularly as relating to FIGS. 2A-I, 13A-18C. Such stabilizingstructures 6200 may have a layer or layers of porous material placed onthe top and/or bottom to create a sandwich-like wound closure device ofthe same general shape when viewed from a birds-eye or top view.

The stabilizing structure or wound closure device, with or without thetop and bottom porous layers, may be shaped into sections A, B, C tocreate smaller stabilizing structures or sandwich-like structures. Moregenerally, the shapes shown in FIGS. 19A-19B may be applicable to anysuitable wound filler, such as foam or other porous material. Cuts 6202(which may indicate designated pre-cut lines in the device or mayindicate desired cutting locations) may be of any shape, direction, orsize. For example, the cuts may be elliptical as depicted in FIGS.19A-B. Designated pre-cut lines may include, but are not limited to,partial or complete cuts through the thickness of the structure,markings or score-lines to facilitate cutting of the device by the useror removal of certain portions of the device by the user. Providing forsuch cuts may be advantageous as a manufacturing technique, allowing theproduction of multiple different modifiable stabilizing structuresand/or wound closure devices with just a single pattern of cuts 6202.

In the right-hand drawing of FIG. 19A, one desired cut pattern mayprovide an elliptical stabilizing structure having a series of cuts 6202that, rather than forming a complete ellipse as in FIG. 19A, form an arcthat may follow the curvature of one side of the elliptical structure(e.g., the left side). For example, these cut lines may be parallel tothe left side or have the same or similar curvature. The ends of thesecuts lines intersect with the outer perimeter of the structure on theright side of the structure. Accordingly, cutting the structure alongthe cut line 6202 between sections A and B will leave a structure formedby section B and C forming a smaller elliptical shape than the initialelliptical shape. Similarly, cutting the structure along the linebetween sections B and C will leave an even smaller elliptical shape.

The stabilizing or sandwich-like structures 6200 may further comprisetissue anchors 6204. In the right-hand drawing of FIG. 19A, by placingthe tissue anchors on the outer surface of the right side of theelliptical structure, such that the anchors extend along a portion ofthe outer perimeters of Sections A, B and C, even if Sections A or B areremoved, anchors will remain on the remaining structure. For example, astructure comprising section C, sections B and C, or sections A, B, andC may be placed in different sizes of wounds in a manner such that theperimeter of the stabilizing structure or wound closure device 6200comprises tissue anchors 6204 which can extend laterally from thestabilizing structure or wound closure device 6200 to engage thesurrounding tissue.

In some embodiments, inner tissue anchors may also be provided withinthe structure, such that once cut, sections A, B, and C have tissueanchors 6204 on additional surfaces than those depicted in FIGS. 19A-B.

FIG. 19B depicts additional or a second set of cuts 6202, which may alsobe elliptical or curved or may have other shapes, defining furthersections D and E. These additional cuts may intersect with the left andright sides of the structure as well as the first cut lines describedabove. As will be understood by one of skill in the art, a wide varietyof possible cuts may be performed to define a wide variety of possibleshapes. Stabilizing Structures and Wound Closure Devices of FIGS. 20A-23

FIGS. 20A-B illustrate a wound closure device 6300 comprisingstabilizing structure 6302, first porous layer 6304, second porous layer6306, first anchoring layer 6308, and second anchoring layer 6310, theanchoring layers comprising tissue anchors such as those described inrelation to FIGS. 5A-D. First anchoring layer 6308 is optionallyattached to first porous layer 6304, while second anchoring layer 6310is optionally attached to second porous layer 6306. In some embodiments,the porous layers 6304, 6306 are unattached to anchoring layers 6308,6310. In certain embodiments the anchoring layers cover at least about10% of the surface area of one side of the porous layer, at least about20%, at least about 30%, at least about 40%, at least about 50%, atleast about 60%, at least about 70%, at least about 80%, at least about90%, or about 100% of the surface area of the porous layers.

Stabilizing structure 6302 may be in the form of any stabilizingstructure described herein this section or elsewhere in thespecification, particularly as relates to FIGS. 2A-I, 5A-D, and 13A-19B.Similar to the other stabilizing structures described herein thissection and elsewhere in the specification, stabilizing structure 6302comprises an outer perimeter 6312 comprising at least one outer wall.For example, the stabilizing structure may have an opposite first side6314A and second side 6314B extending along the length of thestabilizing structure and an opposite third side 6316A and a fourth side6316B extending along the width of the stabilizing structure.

Stabilizing structure 6302 may further be shaped in any manner describedherein this section or elsewhere in the specification such as isdescribed in relation to Steps 3-4 of FIG. 10A. For example, stabilizingstructure 6302 may be shaped in a manner so as to be suitable forplacement within a wound.

In certain embodiments, to minimize the sequence of steps required by aclinician to place the wound closure device 6300 within a wound, woundclosure device 6300 may be pre-packaged with its complete perimeter 6312covered with porous foam and/or tissue anchoring layers. However, thisembodiment may be disadvantageous because once the stabilizing structureis cut and shaped to the shape of the wound, the outer perimeter 6312 ofthe device will no longer comprise porous and anchoring layers. Instead,only a portion of the perimeter will still comprise intact porous andanchoring layers. Thus, in particular embodiments as depicted in FIGS.20A-B, to facilitate the exposure of tissue anchoring layers 6308, 6310and porous layers 6304, 6306 to the surrounding tissue after shaping,first porous layer 6304 may be pre-attached to only a part of the outerperimeter 6312 of the stabilizing structure 6302. In certainembodiments, the portion of first porous layer 6304 comprising firstanchoring layer 6308 may be attached to a first side 6014A of theperimeter of stabilizing structure 6302, while the porous layerunattached to an anchoring layer 6308 may be attached to third side6316A of the stabilizing structure 6302. In other embodiments, theporous layer 6304 may be applied without an anchoring layer 6308.

As depicted in FIG. 20B, once the stabilizing structure 6302 has beenshaped, second porous layer 6306 comprising second anchoring layer maybe attached to remaining perimeter 6312 of the stabilizing structure6302 uncovered by first porous layer 6304, thereby surrounding theentire perimeter of the stabilizing structure with porous layers 6304,6308. In some embodiments, second porous layer may need to be trimmed tosuitably wrap around the entire perimeter of stabilizing structure 6302.During shaping, first porous layer 6304 may be shaped along with thestabilizing structure due to first porous layer's adherence to thestabilizing structure. While shaping first porous layer, first anchoringlayer 6308 may also be shaped due to first anchoring layer's attachmentto first porous layer. The second layer 6306 may be have secondanchoring layer attached to it only in a portion of the second layer6306 attached to one side of the stabilizing structure (e.g., secondside 6314B). Alternatively, the second anchoring layer may be attachedto the portion of the second layer 6306 also attached to the fourth side6316B of the stabilizing structure.

In some embodiments, first porous layer 6304 is only attached to twosides of the stabilizing structure 6302, such as a longitudinal flatside 6314A and a zig-zag side 6316A. However, first porous layer 6304may also be attached to only one side of the stabilizing structure or tothree sides.

FIG. 20C is a photograph of first porous layer or second porous layerbefore it is applied to a shaped stabilizing structure. As illustrated,an anchoring layer may only partially cover the porous layer. In someembodiments, anchoring layer 6308, 6310 may comprise different types ofanchoring layers such as has been previously described in relation toFIGS. 5A-D.

FIG. 21 is a photograph of an embodiment of a foam layer 4600 that maybe used in combination with any of the stabilizing structures or woundclosure devices described in this section or elsewhere in thisspecification. As described above, the foam layer 4600 may be locatedabove or below the stabilizing structure or wound closure device. Insome embodiments, the foam layer 4600 is located both above and belowthe stabilizing structure or wound closure device. The foam layer 4600can surround the perimeter of the stabilizing structure or wound closuredevice or completely surround the entirety of the stabilizing structureor wound closure device. The foam layer 4600 can be constructed fromabsorbent materials, materials configured to distribute fluid, or both.

The foam layer 4600 further comprises fingers 4602, that can extend fromthe foam layer into the stabilizing structure or closure device. Forexample, the fingers 4602 may extend into and around the gaps or cellsdepicted in the stabilizing structures described herein this section orelsewhere in the specification. The fingers 4602 may also extend aroundthe outside of the perimeter of the stabilizing structure. In someembodiments, the fingers 4602 from one foam layer 4600 may extendthrough the interior or around the outside of the stabilizing structureto meet the fingers 4602 from a second foam layer 4600. Thus, one foamlayer will be facing finger-side up, while a second foam layer may befacing finger-side down.

In some embodiments, the foam layer 4600 can have perforations orpre-cuts to allow portions of the foam layer 4600 to be easily torn awayto shape the foam for a particular wound. In some embodiments, thefingers 4602 can extend at least about 1 mm from the surface of the foamlayer, at least about 3 mm from the surface of the foam layer, at leastabout 5 mm from the surface of the foam layer, at least about 7.5 mmfrom the surface of the foam layer, at least about 10 mm from thesurface of the foam layer, at least about 12.5 mm from the surface ofthe foam layer, at least about 25 mm from the surface of the foam layer,at least about 17.5 mm from the surface of the foam layer, at leastabout 20 mm from the surface of the foam layer, at least about 25 mmfrom the surface of the foam layer, or more than 25 mm.

FIGS. 22A-C are photographs of an embodiment of a wound closure device6350 comprising a stabilizing structure 6302 (similar to the stabilizingstructure described above in relation to FIGS. 2A-I and 13A-D), firstporous layer 6304 (not shown in FIGS. 22B and 22C), a top porous layer6352, and a bottom porous layer 6354. Stabilizing structure 6302 incombination with first porous layer 6304 functions as described above inrelation to FIGS. 20A-B. However, in this instance, stabilizingstructure 6302 can be further encased on the top and bottom by porouslayers 6352, 6354, and may be pre-attached to the stabilizing structure6302. Top and bottom porous layers 6352 and 6354 may be shaped in anydesired manner to conform to the shape of stabilizing structure 6302.FIG. 22D illustrates an embodiment where a second porous layer 6306 isattached to the stabilizing structure 6302 after the stabilizingstructure having upper and lower porous layers 6352 and 6354 has beenappropriately sized.

In some embodiments, top and bottom porous layers 6352, 6354 may be inthe form of an egg crate shape, such as the shape described in greaterdetail above in relation to FIG. 21 . In further embodiments, top andbottom layers 6352 and 6354 may be placed about stabilizing structure6302 in any manner described above in relation to FIG. 21 .

In certain embodiments, once the top 6352 and bottom 6354 layers of foamhave been applied, wound closure device 6350 may be shaped to thedesired shape of the wound, thereby eliminating the step of furthershaping the top and bottom porous layers as depicted in FIGS. 9A-10C. Insome embodiments, the top and bottom layers may further comprise tissueanchors such as those described elsewhere in the specification such asin relation to FIGS. 5A-5D.

FIG. 23 illustrates an embodiment of a wound closure device 6400(similar to the wound closure devices depicted in relation to FIGS.2A-I, 13A-14C, and 16A-18C) comprising a stabilizing structure 6402 andconfigured to anchor to the surrounding tissues 6404. In certainembodiments, a porous layer 6406, similar to the porous layer describedabove in relation to FIGS. 20A-C, may be attached to at least a portionof the stabilizing structure 6402. The porous layer comprises a lowerlip 6412 that extends outwardly beneath the tissues surrounding thewound such as the fascia, and an upper lip 6410 that extends outwardlyfrom the stabilizing structure over the tissue surrounding the wound,such as the dermis. In certain embodiments, the porous layer comprisestissue anchors 6408, similar to the tissue anchors described above inrelation to FIGS. 5A-D. The tissue anchors may allow the porous layer toengage the surrounding tissues and thereby better adhere the stabilizingstructure 6402 within the wound. In certain embodiments, the tissueanchors may be present on the upper lip 6410, the lower lip 6412, thecentral portion 6414, or any combination of the three.

In particular embodiments, some or all of the tissue anchors 6408 may bereplaced with an adhesive. For example the lower lip 6412 and centralportion 6414 may comprise tissue anchors while the upper lip 6408comprises an adhesive. In further embodiments, the wound closure device6400 may further comprise porous layers on the top and bottom, similarto the wound closure device depicted in FIGS. 22A-D.

In some embodiments, the wound closure device 6400 (when viewed from theside as in FIG. 23 ) may be in shapes that differ from the square shapeillustrated in FIG. 23 . For example, the device may be a continuouscurve such that the outer side has a concave configuration. In someembodiments, portions of the outer perimeter of the stabilizingstructure 6402 may be in a concave shape so as to facilitate gripping ofthe surrounding tissues.

Porous Pads and Stabilizing Structures of FIGS. 24-27B

Turning to FIG. 24 , similar to the system described above in relationto FIG. 1 , treatment of a wound with negative pressure in certainembodiments uses a negative pressure treatment system 1010 asillustrated schematically here. In this embodiment, a wound site 1100,illustrated here as an abdominal wound site, may benefit from treatmentwith negative pressure. Such abdominal wound sites may be a result of,for example, an accident or due to surgical intervention. In some cases,medical conditions such as abdominal compartment syndrome, abdominalhypertension, sepsis, or fluid edema may require decompression of theabdomen with a surgical incision through the abdominal wall to exposethe peritoneal space, after which the opening may need to be maintainedin an open, accessible state until the condition resolves. Otherconditions may also necessitate that an opening—particularly in theabdominal cavity—remain open, for example if multiple surgicalprocedures are required (possibly incidental to trauma), or there isevidence of clinical conditions such as peritonitis or necrotizingfasciitis.

In cases where there is a wound, particularly in the abdomen, managementof possible complications relating to the exposure of organs and theperitoneal space is desired, whether or not the wound is to remain openor if it will be closed. Therapy, preferably using the application ofnegative pressure, can be targeted to minimize the risk of infection,while promoting tissue viability and the removal of deleterioussubstances from the wound site. The application of reduced or negativepressure to a wound site has been found to generally promote fasterhealing, increased blood flow, decreased bacterial burden, increasedrate of granulation tissue formation, to stimulate the proliferation offibroblasts, stimulate the proliferation of endothelial cells, closechronic open wounds, inhibit burn penetration, and/or enhance flap andgraft attachment, among other things. It has also been reported thatwounds that have exhibited positive response to treatment by theapplication of negative pressure include infected open wounds, decubitusulcers, dehisced incisions, partial thickness burns, and various lesionsto which flaps or grafts have been attached. Consequently, theapplication of negative pressure to a wound site 1100 can be beneficialto a patient.

Accordingly, certain embodiments provide for a wound contact layer 1050to be placed over the wound site 1100. Preferably, the wound contactlayer 1050 can be a thin, flexible material which will not adhere to thewound site or the exposed viscera in close proximity. For example,polymers such as polyurethane, polyethylene, polytetrafluoroethylene, orblends thereof may be used. In one embodiment, the wound contact layeris permeable. For example, the wound contact layer 1050 can be providedwith openings, such as holes, slits, or channels, to allow the removalof fluids from the wound site 1100 or the transmittal of negativepressure to the wound site 1100. Additional embodiments of the woundcontact layer 1050 are described in further detail below.

Certain embodiments of the negative pressure treatment system 1010 mayalso use a porous pad 1030, which can be disposed over the wound contactlayer 1050. This pad 1030 can be constructed from a porous material, forexample foam, that is soft, resiliently flexible, and generallyconformable to the wound site 1100. Such a foam can include anopen-celled and reticulated foam made, for example, of a polymer.Suitable foams include foams composed of, for example, polyurethane,silicone, hydrophobic materials, hydrophilic materials, open-celledmaterials, close-celled materials, mixed open and close-celledmaterials, reticulated materials, polyester, silicone, and/or polyvinylalcohol. In certain embodiments, the term “open-celled” may refer to amaterial (such as foam) that comprises just enough open pores to allowfluid to be transmitted when the foam is compressed at pressures of atleast about: −350 mmHg, −300 mmHg, −200 mmHg, −150 mmHg, −120 mmHg, −75mmHg, −50 mmHg, −25 mmHg or −5 mmHg. In some embodiments, theopen-celled material may have a wide range of suitable porosities andthe pores may be of a variety of suitable sizes. Preferably, this pad1130 can channel wound exudate and other fluids through itself whennegative pressure is applied to the wound. Some pads 1030 may includepreformed channels or openings for such purposes. In certainembodiments, the pad 1030 may have a thickness between about one inchand about two inches. The pad may also have a length of between about 16and 17 inches, and a width of between about 11 and 12 inches. Forexample, the length of the pad can range from between about 1 to 50inches, between about 3 to 40 inches, between about 5 to 30 inches,between about 10-20 inches, or between about 14 to 18 inches. Further,for example, the width may range from about 1 to 20 inches, 5 to 15inches, or 8 to 12 inches. In other embodiments, the thickness, width,and/or length can have other suitable values. Other aspects of the pad1030 are discussed in further detail below.

Preferably, a drape 1070 is used to seal the wound site 1100. The drape1070 can be at least partially liquid impermeable, such that at least apartial negative pressure may be maintained at the wound site. Suitablematerials for the drape 1070 include, without limitation, syntheticpolymeric materials that do not significantly absorb aqueous fluids,including polyolefins such as polyethylene and polypropylene,polyurethanes, polysiloxanes, polyamides, polyesters, and othercopolymers and mixtures thereof. The materials used in the drape may behydrophobic or hydrophilic. Examples of suitable materials includeTranseal® available from DeRoyal and OpSite® available from Smith &Nephew. In order to aid patient comfort and avoid skin maceration, thedrapes in certain embodiments are at least partly breathable, such thatwater vapor is able to pass through without remaining trapped under thedressing. An adhesive layer may be provided on at least a portion theunderside of the drape 1070 to secure the drape to the skin of thepatient, although certain embodiments may instead use a separateadhesive or adhesive strip. Optionally, a release layer may be disposedover the adhesive layer to protect it prior to use and to facilitatehandling the drape 1070; in some embodiments, the release layer may becomposed of multiple sections.

The negative pressure system 1010 can be connected to a source ofnegative pressure, for example a pump 1140. One example of a suitablepump is the Renasys EZ pump available from Smith & Nephew. The drape1070 may be connected to the source of negative pressure 1140 via aconduit 1120. The conduit 1120 may be connected to a port 113 situatedover an aperture 1090 in the drape 1070, or else the conduit 1120 may beconnected directly through the aperture 1090 without the use of a port.In a further alternative, the conduit may pass underneath the drape andextend from a side of the drape. U.S. Pat. No. 7,524,315, filed Oct. 28,2003 discloses other similar aspects of negative pressure systems and ishereby incorporated by reference in its entirety and should beconsidered a part of this specification.

In many applications, a container or other storage unit 1150 may beinterposed between the source of negative pressure 1140 and the conduit1120 so as to permit wound exudate and other fluids removed from thewound site to be stored without entering the source of negativepressure. Certain types of negative pressure sources—for example,peristaltic pumps—may also permit a container 1150 to be placed afterthe pump 1140. Some embodiments may also use a filter to prevent fluids,aerosols, and other microbial contaminants from leaving the container1150 and/or entering the source of negative pressure 1140. Furtherembodiments may also include a shut-off valve or occluding hydrophobicand/or oleophobic filter in the container to prevent overflow; otherembodiments may include sensing means, such as capacitative sensors orother fluid level detectors that act to stop or shut off the source ofnegative pressure should the level of fluid in the container be nearingcapacity. At the pump exhaust, it may also be preferable to provide anodor filter, such as an activated charcoal canister.

With reference to FIGS. 25A-B, perspective and top views of anembodiment of the porous pad 1030 are shown. The pad 1030 preferably hasone or more perforations made thereon, illustrated for example atarcuate cuts 202, 204, 208, and 210. These cuts may be formed on the pad1030 using any suitable mechanism, including, for example but without,limitation cutting blades, die cutting, or hot wire cutting, and thesecuts preferably extend through at least portion of the thickness of thepad 1030. The cuts do not need to be continuous, and may consist, forexample, of multiple small perforations. In one embodiment, perforationsextend entirely across the thickness of the pad 1030. In order to ensurethat the pad 1030 remains structurally intact during handling and use,the cuts made through the pad 1030 preferably retain one or more smallbridge portions, such as the bridge portion 206.

In some embodiments, the pad 1030 has a substantially rectangular shapehaving a length L, a width W, and a thickness T defined about a majoraxis X, a minor axis Y, and a vertical axis Z, and has four roundedcorners. A first series of arcuate outer cuts 202 may be formed in thepad in an elliptical shape. In the illustrated embodiment, there arefour outer cuts 202 a, 202 b, 202 c and 202 d, each positioned in one ofthe quadrants defined by the axes X and Y, with four bridge portions 206positioned at opposite ends along the major and minor axes. Interior tothe outer cuts 202 are a series of arcuate inner cuts 210 also having anelliptical shape similarly shaped to the series of arcuate outer cuts202. As illustrated, in one embodiment there are four inner cuts 210 a,210 b, 210 c, 210 d also each positioned in one of the quadrants definedby the axes X and Y, with four bridge portions 222 positioned atopposite ends along the major and minor axes.

In certain embodiments, located between the outer and inner cuts 202 and210 may be a series of intermediate cuts 204 and 208. From the top viewperspective of FIG. 25B, an upper arcuate cut 204 a and a lower arcuatecut 204 b are symmetrically arranged about minor axis Y located atopposite ends of the pad 1030. Cuts 204 a and 204 b extend generallyacross the width W of the pad, symmetrically about major axis X, withthese cuts 204 a, 204 b having a larger radius of curvature than that ofthe arcuate cuts 202 near the major axis X. Left and right arcuate cuts208 are provided between the arcuate cuts 204 a, 204 b, extendinggenerally length-wise across the pad. As illustrated, there may be fourarcuate cuts 208 a, 208 b, 208 c, 208 d, each extending generallyparallel to the portions of the arcuate cuts 202, 210 that surroundthem, with bridge portions 220 located on the minor axis Y. It will beappreciated that the shape and number of cuts may be varied, and thatthere may be more than one series of intermediate cuts between the innerand outer cuts 210, 202.

Advantageously, cuts made on the pad 1030 can be used to selectivelysize the pad 1030 to the wound site in which the pad 1030 is to beplaced. For example, the pad 1030 can be sized by removing detachablesections from the pad 1030, for example, outer section 218 thatsurrounds outer cuts 202, inner sections 212 a, 212 b located betweenthe outer cuts 202 and intermediate cuts 204 a and 204 b, and innersections 214 a, 214 b between the outer cuts 202 and intermediate cuts208. Although additional and different cuts from the cuts 202, 204, 208,and 210 may be made on the pad 1030, these cuts represent examples oftypes and locations of cuts that can be used to size a pad in adimensionally-independent manner. Types of cuts that can be made on thepad 1030 include, for example, arcuate, circular, ovoid, zigzag, and/orlinear cuts. Further, although the cuts shown here are along the lengthL and width W of the pad, similar cuts may be made along the thickness Tof pad 1030, such that a thinner pad can be used in a wound site. Cutsmay also be made at an angle not aligned with either of the X, Y, or Zaxes, for example diagonally across the pad 1030.

In use, the pad 1030 may be too large for the wound site 110, and mayneed to be sized by removing the detachable area 218 encompassed by theedges of the pad 1030 and the cuts 202 made thereon. For smaller wounds,detachable areas 212 a, 212 b, 214 a, and 214 b may all be removed toleave only the detachable areas 216 and 217. In even smaller wounds, theremainder of the pad 1030 may be removed to leave only the centraldetachable area 216. Typically, such sizing can be performed manually,for example using scissors, but such methods incur concomitantdisadvantages such as difficulties in manipulating a cutting utensil ina busy operating room, uneven and imprecise cuts, and the possibility ofshedding foreign particles into a wound site. Instead, the premade cutson the pad 1030 may be detached by hand or with minimal cutting alongthe various bridge portions 206, 220, 222.

With continued reference to FIGS. 25A-B, certain embodiments permitsizing of a pad 113 in a dimensionally-independent manner. Here,sections from the pad 1030 can be detached or cut along the delineationsbetween the various cuts, for example the sections 212 a, 212 b and 214a, 214 b. These cuts 204 and 208 can permit sizing of the pad 1030 asdesired to more closely tailor the actual dimensions of a wound site.For example, sizing a pad 1030 for fitting in a wound that is wider onthe left side and narrower on the right side may be effectuated byremoving a pad section 214 a delineated between the cuts 208 a, 208 band 202 a, 202 b. In another example, where the pad 1030 is longer alongits top portion than the wound site 110, a pad section 212 a, delineatedbetween cuts 202 a, 202 b, and 204 a can be removed from one end of thepad 1030. In these preceding examples, the outer detachable portion 218has preferably already been removed, although this is not necessarilyrequired. Consequently, dimensionally-independent sizing of the pad 1030(e.g., modifying the length of the pad without altering the width of thepad, and vice-versa) may be achieved by detaching sections 212, 214delineated by cuts 204 or 208. Additional detachable sectionsencompassed by additional cuts so as to permit dimensionally-independentsizing of the pad 1030 are contemplated, and the embodiments illustratedherein are not intended to be limiting. Obviously, for smaller woundsites, the removal of symmetric sections of the pad 1030 may still beuseful, and embodiments of the pad 113 may provide such sections,illustrated here as sections 218, 217, 216. For example, removal of theouter section 218 of the pad 1030 along the cuts 202 may be necessary.Similarly, for smaller incisions only the inner section 216 delineatedinside cuts 210 may be required.

FIG. 25C illustrates an alternative embodiment of a foam pad 300,similar to the pads depicted in FIGS. 25A-B, however, the pattern ofcuts 302 depicted in FIG. 3 may differ from the cuts depicted in FIGS.25A-B. In certain embodiments, the pad 300 may comprise multipleconcentric elliptical cuts 302. The cuts may encompass a complete 360degree ellipse or they can encompass a partial cut that does notcomprise the entirety of an ellipse. For example, a cut may compriseless than at least 10 degrees, at least 10 degrees, at least 30 degrees,at least 60 degrees, at least 90 degrees, at least 120 degrees, at least180 degrees, at least 240 degrees, at least 300 degrees, or at least 360degrees. In particular embodiments, the pad may contain at least oneelliptical cut, at least two elliptical cuts, at least three ellipticalcuts, at least four elliptical cuts, at least five elliptical cuts, atleast ten elliptical cuts, or more than 10 elliptical cuts. As with thepad embodiments and methods depicted in relation to FIGS. 25A-B, thecuts may allow for sections of foam to be removed from the pad to allowthe pad to be shaped to the form of a wound.

FIG. 26 depicts an embodiment of a three-dimensional foam structure 400,similar to the foam pads depicted in FIGS. 25A-C. The foam structure maycomprise a foam material with a number of cuts or perforations 402 inthe x, y, and z dimensions. The cuts or perforations may createfrangible regions within the structure that can be selectively removedfrom the structure. Such cuts or perforations 402 may allow the foamstructure 400 to be modified in a dimensionally-independent manner,similar to the dimensionally-independent modification of the foam padsdepicted in FIGS. 25A-C. For example, the frangible regions of thestructure 400 may be selectively removed to alter the structure in the xdimension, the y dimension, and the z dimension, to shape the structureinto the shape of a wound. Further details regarding the shaping of athree-dimensional to the shape of a wound may be found in U.S.application Ser. No. 13/201,427, titled WOUND PACKING, filed Sep. 14,2011, and published as US 2011/0319804. This application is herebyincorporated by reference in its entirety.

In certain embodiments, the foam structure may be in the form of anovoid, a cube, or other suitable three-dimensional shape. The foamstructure 400 may be used in combination with any suitable negativepressure wound therapy system or apparatus described herein this sectionor elsewhere in the specification.

FIGS. 27A-B depict embodiments of a porous pad 5200, similar to the padsand structures described above in relation to FIGS. 24-26 . Although theword “pad” 5200 will be used in this section, any description relatingto the pad is also applicable to the three-dimensional “structure” 400described in FIG. 26 .

In certain embodiments, the porous pad 5200 of FIGS. 27A-B may comprisea series of cuts or perforations 5202, similar to the cuts described inrelation to FIGS. 25A-26 . The pad may be comprised of a porous material5204, such as those materials described in relation to FIGS. 25A-26 ,and other materials described herein this section and elsewhere in thisspecification. The pad may further comprise one or more stabilizingstructures 5006, 5008 embedded within the porous material 5204. Suchstabilizing structures are similar to the structures described above inrelation to FIGS. 2A-2I, 13A-14C, and 16-18C. The stabilizing structuresmay be completely encased within the surrounding porous material 5204,such that the stabilizing structures are completely surrounded by theporous material in all directions. In certain embodiments, portions ofthe stabilizing structures may protrude from the porous material. Forexample, the stabilizing structures may protrude from the top, bottom,or sides of the porous material.

As will be understood by one skilled in the art, the stabilizingstructures are not limited to a side by side arrangement in atwo-dimensional plane. Instead, with reference to the three-materialstructure embodiments described elsewhere in reference to FIG. 26 , thestabilizing structures may also be arranged along the height of thestructure in three dimensions.

In certain embodiments, the cuts or perforations 5202 in pad 5200through porous material 5204 may be of any type described herein thissection or elsewhere in the specification, particularly as relates toFIGS. 25A-26 . As described elsewhere, particularly in relation to FIGS.25A-26 , the cuts or perforations may allow frangible regions of the pad5200 or three-dimensional structure to be detached so as to shape thepad or three-dimensional structure to the shape of a wound. In certainembodiments, the stabilizing structures 5206 and 5208 are completelycontained within the detachable regions. In other embodiments, thestabilizing structures may extend between frangible regions, and thusthe stabilizing structures themselves may be separable. For example, thestabilizing structures may have cuts or perforations similar to thosecuts or perforations in the porous material 5204. In particularembodiments, the frangible stabilizing structures may not be surroundedby any porous material, instead they may be shaped to the shape of awound without the use of an encasing porous material. Further, any ofthe stabilizing structure embodiments described herein this section orelsewhere in the specification may be frangible and capable of beingshaped even in the absence of an encasing porous material. In certainembodiments, frangible regions of the stabilizing structure may beadhered to one another via an adhesive.

The stabilizing structures may be of a variety of shapes and sizes suchas those described herein this section or elsewhere in thespecification. Further, different types of stabilizing structures may beincorporated into a single porous pad 5200. For example, as depicted inFIG. 27A, the porous pad 5200 may be comprised of two types ofstabilizing structures, a smaller-celled stabilizing structure 5206, anda larger-celled stabilizing structure 5208. As illustrated in FIG. 27A,the larger-celled structure may be contained within the central portionof the porous pad 5200, while the smaller-celled stabilizing structurecan be contained throughout the outer regions. In certain embodiments,the larger-celled structures may be contained within the outer regionsof the porous pad 5200, while the smaller-celled structures may becontained within the central portions. The porous pad may be surroundedby a flexible annular outermost region 5210. In some embodiments, theremay be additional similar regions, allowing for further frangibleregions.

In particular embodiments, a portion of the pad containing only porousmaterial may extend beyond the sections of the pad that comprise astabilizing structure. This extending porous material-only portion ofthe pad may extend above, beneath or between layers of surroundingtissue, such as the skin, fatty tissue, fascia, muscle, or othersuitable tissues. In some embodiments, this porous material-only portionof the pad may extend for less than one inch, at least 1 inch, at least2 inches, at least 4 inches, at least 8 inches, at least 12 inches, atleast 15 inches, or more than 15 inches.

As depicted in FIG. 27B, the porous pad 5200 may be comprised oflarger-celled stabilizing structures 5208 within the central region andsurrounding regions, while the smaller-celled stabilizing structures5206 are contained only within the flexible outermost region 5210. Infurther embodiments, the porous pad may comprise more than two types ofstabilizing structures. For example, the porous pad may comprise atleast three types of stabilizing structures, at least four types ofstabilizing structures, at least five types of stabilizing structures,at least six types of stabilizing structures, or more than six types ofstabilizing structures. In certain embodiments, all of the stabilizingstructures are of the same type, i.e. have cells of the same size.

The stabilizing structures 5206, 5208 may be configured to collapse inany manner described herein this section or elsewhere in thespecification such as in relation to FIGS. 2A-2I, 13A-14C, and 16-18C.Briefly, as described in detail elsewhere, the stabilizing structures5006 and 5008 can be configured to collapse more readily under negativepressure in a first direction, while not collapsing to a significantdegree in a second direction. Further, various stabilizing structuresmay have different collapsibility properties as described herein thissection or elsewhere in the specification.

In certain embodiments, the stabilizing structure may be of any typedescribed herein this section or elsewhere in this specification.Further, the stabilizing structure may be comprised of any of thematerials described herein this section or elsewhere in thespecification. In some embodiments, the porous pads 5200 depicted inFIGS. 27A-B may be surrounded by an anchoring layer such as thosedescribed in relation to FIGS. 4-5D. The anchoring layer may be attachedto the porous pad in any manner described herein this section orelsewhere in the specification. For example, the anchoring layer may beattached by an adhesive and/or via tape.

In some embodiments, the porous pad 5200 may further comprise tissueanchors similar to those described in relation to FIGS. 4-5D. Similar tothe embodiments described in relation to FIGS. 4-5D, the tissue anchorscan be hooks, barbs, prongs, or other structures that serve to attach tothe tissue of a wound. In some embodiments, the tissue anchors comprisehook and loop fasteners such as those used in Velcro technologies. Theanchors may extend from the stabilizing structures or from the foamportions of the porous pad.

In some embodiments, the porous pads 5200 may be manufactured by forminga porous material around the stabilizing structures and then creatingcuts and/or perforations via any method described herein this section orelsewhere in the specification. In certain embodiments, the porous padmay contain a single internal pocket or multiple internal pockets forinsertion of the stabilizing structures. For example, each frangibleregion may have a pocket to allow for insertion of a stabilizingstructure. In some embodiments, the porous material may be initiallysliced in two, such that the stabilizing structure is placed within onceportion of the porous material and then covered by a second portion ofthe porous material.

Mechanism for Preventing Collapse of Wound Closure Device (FIGS. 28-39)

In some embodiments, the stabilizing structure used in wound closuredevices as described herein comprises a plurality of cells providedside-by-side in a plane, each cell defined by one or more walls, eachcell having a top end and a bottom end with an opening extending throughthe top and bottom ends in the direction perpendicular to the plane. Thestabilizing structure is configured to collapse more within the planethan along the direction perpendicular to the plane. The plane mayextend in a horizontal direction parallel with a tissue surface, and thewalls extend in a vertical direction perpendicular to the tissuesurface. In certain embodiments, the stabilizing structure comprises aplurality of elongate strips, and a plurality of intervening membersconnecting the elongate strips, wherein the plurality of interveningmembers are configured to pivot relative to the strips to allow theplurality of elongate strips to collapse relative to one another.

FIGS. 28-32 show one embodiment of a wound closure device 5300. Thewound closure device 5300 can have a stabilizing structure 4200 with oneor more strips 4202 interconnected by one or more intervening members4204 joined to the one or more strips 4202 via joints 4206. As discussedabove, the strips 4202 and intervening members 4204 define a pluralityof cells 4210 side by side in a plane 5308 (e.g., defined by page inFIG. 29 ), each of the cells 4210 defined between two adjacent strips4202 and two adjacent intervening members 4204 and having an opening5307 that extends from a top end 5303 to a bottom end 5305 of thestabilizing structure 4200 in a direction perpendicular to the plane5308. As described above, the stabilizing structure 4200 can collapsealong the plane such that the one or more strips 4202 move toward eachother (e.g., adjacent each other) as the intervening members 4204 pivotrelative to the strips 4202 (e.g., as the cells 4210 collapse).

With continued reference to FIGS. 28-32 , the wound closure device 5300can also include a support structure 6500. The support structure 6500can attach to the stabilizing structure 4200. The support structure 6500can at least partially inhibit or prevent the collapse of thestabilizing structure (e.g., when a negative pressure is applied to thewound closure device 5300).

In one embodiment, the support structure 6500 can include a plurality ofsupport elements 6501 that can couple to each other to define theassembled support structure 6500. The support structure 6500 is thusmodular and the size of the support structure 6500 can be varied atleast by varying the number of support elements 6501 that are coupled toeach other.

Each of the support elements 6501 can optionally include one or morebeams 6510 that (e.g., together) define a length of the support element6501 and one or more cross-beams 6520 that define a width of the supportelement 6501, where each beam 6510 extends between and attaches to apair of cross-beams 6520. In one embodiment, the beams 6510 andcross-beams 6520 can be perpendicular to each other (e.g., form aT-shape). However, in other embodiments, the beams 6510 and cross-beams6520 can be at other suitable angles relative to teach other. Eachcross-beam 6520 can have a pair of opposite ends 6530, wherein each ofthe ends 6530 of one support element 6501 of the support structure 6500can couple to an end 6530 of another support element 6501 of the supportstructure 6500, as further discussed below.

In one embodiment the one or more beams 6510 can have a frangibleportion or joint 6540 (e.g., portion of reduced thickness), that allowsthe beam 6510 to be detached (e.g., broken, tom, cut) from the rest ofthe support element 6501 via the frangible portion 6140. Therefore, thesize (e.g., length) of the support element 6501 can be adjusted at leastby detaching one or more beams 6510 therefrom via the frangible portion6540, for example, in addition to being adjusted by the number ofsupport elements 6501 that are coupled to each other. In one embodiment,the frangible portion 6540 is defined at the junction of the beam 6510and cross-beam 6520. However, in other embodiments, the frangibleportion 6540 can be defined in another portion of the beam 6510 (e.g.,midway along the beam). In one embodiment, only one end of the beam 6510has the frangible portion 6540. In another embodiment, both ends of thebeam 6510 have the frangible portion 6540.

As discussed above, a plurality of support elements 6501 can be coupledtogether to form the support structure 6500 by coupling the ends 6530 ofthe cross-beams 6520 of adjacent support elements 6501 together. Withreference to FIGS. 31-32 , the ends 6530 of the cross-beams 6520 can inone embodiment have a C-shaped opening 6532 and one or more notches 6534that couple (e.g. clip) onto a boss portion 6562 of a pin 6560 attachedto a cylinder member 6552 of an insert 6550 that extends into a cell4210 of the stabilizing structure 4200. In one embodiment, the bossportion 6562 can be square shaped and have a length sized to allow twoends 6530 of cross-beams 6520 of adjacent support elements 6501 tocouple thereto. However, in other embodiments, the boss portion 6562 canhave other suitable shapes (e.g., round). In one embodiment, the pin6560 and cylinder member 6552 can be one piece (e.g., monolithic). Inanother embodiment, the pin 6560 can be removably inserted into acorresponding opening in the cylinder member 6552.

The insert 6550 can also include a wall 6554 attached to the cylindermember 6552, where the wall 6554 can contact (e.g., bear against) asurface of an adjacent strip 4202. The support structure 6500 caninclude a plurality of inserts 6550 attached to the support elements6501 via the pins 6560 and ends 6530 of the cross-beams 6520, asdiscussed above.

In one embodiment, the support structure 6000 can be made of a rigid orsemi-rigid material. For example, in one embodiment, the supportstructure 6000 can be of a rigid polymer material. However, othersuitable materials (e.g., plastic materials) can be used.

During use, the size stabilizing structure 4200 can be adjusted orvaried in the manner described above. The support structure 6000 canthen be sized (e.g., by the number of support elements 6501 that arecoupled together and/or the beams 6510 removed via the frangibleportions 6540) and attached to the stabilizing structure 4200. In oneembodiment, the one or more inserts 6550 of the support structure 6000are inserted into one or more cells 4210 of the stabilizing structure4200 so that support elements 6501 contact the top end 5302 of thestabilizing structure 4200 (e.g., extend a long a plane parallel to theplane 5308). In another embodiment, the one or more inserts 6550 of thesupport structure 6500 are inserted into one or more cells 4210 of thestabilizing structure 4200 so that support elements 6501 contact thebottom end 5005 of the stabilizing structure 4200. In one embodiment,the top end 5302 of the stabilizing structure 4200 has a plurality ofnotches 4220 on an edge of one or more strips 4202 to allow the removalof fluids from the wound site (e.g., when negative pressure is applied).In another embodiment, the plurality of notches 4220 are instead definedon the bottom end 5304 of the stabilizing structure 4200.

In one embodiment, the support structure 6500 can attach to thestabilizing structure 4200 by inserting the one or more inserts 6550into the cells 4210 of the stabilizing structure 4200 and so that thesupport elements 6501 are adjacent (e.g., contact) an end of thestabilizing structure 4200. In another embodiment, the support structure6500 couples onto the stabilizing structure 4200 via one or more clipmembers (not shown) such that the support structure 6000 locks onto thestabilizing structure 4200.

In one embodiment, the support structure 6500 can be sized to correspondto the size of the stabilizing structure 4200, such that when attachedto the stabilizing structure 4200 the support structure 6500 inhibits(e.g., prevents) the collapse of substantially the entire (e.g., all)stabilizing structure 4200 (e.g., when negative pressure is applied tothe wound closure device 5300.

In another embodiment, the support structure 6500 can be sized tocorrespond to a size smaller than the size of the stabilizing structure4200, such that when attached to the stabilizing structure 4200 thesupport structure inhibits (e.g., prevents) the collapse of a portion ofthe stabilizing structure 4200 while another portion of the stabilizingstructure 4200 (to which the support structure 6500 is not attached) isallowed to collapse (e.g., when negative pressure is applied to thewound closure device 5300).

FIGS. 33-39 show another embodiment of a wound closure device 5300′. Thewound closure device 5300′ can have a stabilizing structure 4200, whichcan be similar in structure as the stabilizing structure 4200 describedabove in connection with FIGS. 28-32 (e.g., have one or more strips 4202interconnected by one or more intervening members 4204 via joints 4206and that define a plurality of cells 4210 side by side in a plane 5008).

The wound closure device 5300′ can include a support structure 6600 thatis expandable (e.g., by introduction of a fluid, such as air, into thesupport structure 6600). In one embodiment, the support structure 6600can include a control valve 6610 in fluid communication with a headermember 6630 (e.g., via a conduit or tube 6620). The header member 6630can be in fluid communication with one or more support elements 6640(e.g., a plurality of support elements 6640). In one embodiment, the oneor more support elements 6640 extend parallel to each other. Each of thesupport elements 6640 can have one or more inserts 6650 (e.g., aplurality of inserts 6650) that extend from one side of the supportelement 6640 and are expandable (e.g., via fluid delivered via theheader member 6630 and support elements 6640 into the inserts 6650. Theinserts 6650 can be sized to fit within the cells 4210 of thestabilizing structure 4200, such that the inserts 6650 can extend intothe cells 4210 and can contact one or more surfaces of the cell 4210(e.g., walls defined by the strips 4202 and intervening members 4204).

In the illustrated embodiment, the support structure 6600 has threesupport elements 6640. However, in other embodiments, the supportstructure 6600 can have more or fewer support elements 6640.

With continued reference to FIGS. 33-39 , the support structure 6600 canhave one or more seals 6660 to seal off at least a portion of the one ormore support elements 6640. In one embodiment, the one or more seals6660 can be disposed between the header member 6630 and the one or moresupport elements 6640. However, in other embodiments, the one or moreseals 6660 an additionally, or alliteratively, be disposed betweenadjacent inserts 6650 of a support element 6640. In one embodiment, theseals 6660 can be plastic zipper type seals or sliderless plastic zippertype seals. The seals 6660 advantageously allow the size of the supportstructure 6600 to be adjusted while allowing the remaining portion ofthe support structure 6600 (e.g., the remaining inserts 6650) to beexpanded via the introduction of a fluid (e.g., air) therein. To adjustthe size of the support structure 6600, a user can actuate the seal 6660adjacent the location of the support structure 6600 to be removed toseal (e.g., close) fluid flow at said location. The desired portion ofthe support structure 6600 downstream of said seal 6660 can then beremoved (e.g., cut, torn) and the remaining inserts 6650 of the supportstructure 6600 expanded via the introduction of said fluid. The closingof said seal 6660 will inhibit (e.g., prevent) loss of fluidtherethrough.

In one embodiment, the support structure 6600 can be sized to correspondto the size of the stabilizing structure 4200 (e.g., by choosing asupport structure 6600 with a number of support elements 6640 andinserts 6650 corresponding to the number of rows of cells 4210 andnumber of cells 4210 in the stabilizing structure 4200). When thesupport structure 6600 is attached to the stabilizing structure 4200such that the inserts 6650 extend into the cells 4210, the supportstructure 6600 inhibits (e.g., prevents) the collapse of substantiallythe entire (e.g., all) stabilizing structure 4200 (e.g., when negativepressure is applied to the wound closure device 5300′.

In another embodiment, the support structure 6600 can be sized tocorrespond to a size smaller than the size of the stabilizing structure4200, such that when attached to the stabilizing structure 4200 thesupport structure 6500 inhibits (e.g., prevents) the collapse of aportion of the stabilizing structure 4200 while another portion of thestabilizing structure 4200 (to which the support structure 6500 is notattached) is allowed to collapse (e.g., when negative pressure isapplied to the wound closure device 5300′).

Mechanism for Maintaining Closure of Wound Closure Device (FIGS. 40-46)

FIGS. 40-46 show one embodiment of a wound closure device 5400. Thewound closure device 5400 can have a stabilizing structure 4200 and haveone or more strips 4202 interconnected by one or more interveningmembers 4204 joined to the one or more strips 4202 via joints 4206. Asdiscussed above, the strips 4202 and intervening members 4204 define aplurality of cells 4210 side by side in a plane 5408 (e.g., defined bypage in FIG. 40 ), each of the cells 4210 defined between two adjacentstrips 4202 and two adjacent intervening members 4204 and having anopening 5406 that extends from a top end to a bottom end of thestabilizing structure 4200 in a direction perpendicular to the plane5408. As described above, the stabilizing structure 4200 can collapsealong the plane such that the one or more strips 4202 move toward eachother (e.g., adjacent each other) as the intervening members 4204 pivotrelative to the strips 4202 (e.g., as the cells 4210 collapse).

With continued reference to FIGS. 40-44 , the wound closure device 5400can also include a mechanism 5402 that can latch, lock or otherwise holdportions of the stabilizing structure when in a collapsed configurationto thereby maintain the stabilizing structure 4200 in the collapsedconfiguration, for example, after negative pressure to the wound closuredevice 5400 is ceased. In one embodiment, the mechanism 5402 can includeone or more latching members 5404 attached to at least one of the one ormore strips 4202. In the illustrated embodiment, a plurality of latchingmembers 5404 are attached to one or more strips 4202 of the stabilizingstructure 4200 such that a portion of the latching member 5204 extendsinto the opening 5406 of each cell 4210.

FIG. 41 shows one embodiment of a latching member 5404. The latchingmember 5404 can have an elongate member 5410, where one surface of theelongate member 5410 can attach to a surface of the one or more strips4202 (e.g., via an adhesive). The latching member 5404 can also includea latching element 5420 that can optionally be spaced apart from theelongate member 5410 and can extend at an angle relative to the elongatemember 5410. In one embodiment, the latching element 5420 can extendsubstantially perpendicular (e.g., at 90 degrees) to the elongate member5410. However, in other embodiments, the latching element 5420 canextend at other suitable angles relative to the elongate member 5410,such as at an angle of less than 90 degrees, or an angle of more than 90degrees.

The latching element 5404 can have an inner surface 5430 and an outersurface 5440. In one embodiment, as shown in FIG. 41A, the inner surface5430 can be curved and the outer surface 5440 can be substantiallyplanar. In the illustrated embodiment, the curved inner surface 5430 canbe concave facing the elongate member 5410. However, in otherembodiments, the inner surface 5430 can be convex facing the elongatemember 5410. In another embodiment, as shown in FIG. 41B, the inner andouter surfaces 5430, 5440 can be generally planar, where the innersurface is angled away from the elongate member 5410 and the outersurface is angled toward the elongate member 5410. In still anotherembodiment, as shown in FIG. 41C, the inner and outer surfaces 5430,5440 can be curved. In the illustrated embodiment, both the inner andouter surfaces 5430, 5440 can be concave. However, in other embodiments,one or both of the inner and outer surfaces 5430, 5440 can be convex.

FIG. 42 shows one embodiment of the latching member 5404 coupled to awall of the stabilizing structure 4200, for example, when thestabilizing structure 4200 is in the collapsed configuration. Thelatching member 5404 can be attached to the one or more strips 4202 sothat the latching element 5420 is proximate a top end of the strip 4202.As the stabilizing structure 4200 moves to the collapsed configuration(e.g., via application of negative pressure to the wound closure device5400, the outer surface 5440 of the latching element 5420 comes incontact with a top edge of the adjacent strip 4202. As the stabilizingstructure 4200 continues to collapse, the top edge of the strip 4202moves past the outer surface 5440 and the apex of the latching element5420 and moves into the space between the inner surface 5430 and theelongate member 5410. The inner surface 5430 can contact the top edge ofthe strip 4202 and inhibit the strip 4202 from moving past the innersurface 5430 and apex of the latching element 5420, thereby acting tomaintain the stabilizing structure 4200 in a collapsed configuration,even after application of negative pressure to the wound closure device5000 has ceased.

As discussed above, the inner and outer surfaces 5430, 5440 of thelatching element 5420 can have various configurations, at least one ofwhich can make it easier (e.g., require less force) for the latchingelement 5420 to latch onto the strip 4202, make it more difficult (e.g.,require a greater force) for the strip 4200 to unlatch from the latchingelement 5420, or both.

In one embodiment, as described above, the latching member 5404 can beattached to the one or more strips 4202 of the stabilizing structure4200. In another embodiment, the one or more latching members 5404 andat least a portion (e.g., a supporting segment 4214) of a correspondingstrip 4202 can be a single piece (e.g., molded as one piece ormonolithic).

FIG. 43 shows another embodiment of a latching member 5450 of amechanism 5402. The latching member 5450 that can latch, lock orotherwise hold portions of the stabilizing structure when in a collapsedposition to thereby maintain the stabilizing structure 4200 in saidcollapsed position, for example, after negative pressure to the woundclosure device 5000 is ceased. The latching member 5450 is similar tothe latching member 5404, except as described below.

The latching member 5450 can have an elongate member 5410 and a latchingelement 5420. In the illustrated embodiment, the latching element 5420has more than one tooth 5422 (e.g., a plurality of teeth 5422), each ofthe teeth having an inner surface 5430 and an outer surface 5440, asdescribed above in connection with the latching member 5450. Themultiple teeth 5422 advantageously allow the mechanism 5402 to latch,secure or otherwise hold the stabilizing structure 4200 in more than onecompressed state. For example, the latching member 5450 can hold thestabilizing structure 4200 in a first compressed state (e.g., 60%compressed) when the strip 4202 latches to a first tooth 5422A, can holdthe stabilizing structure 4200 in a second compressed state (e.g., 40%compressed) when the strip 4202 latches to a second tooth 5422B, and canhold the stabilizing structure 4200 in a third compressed state (e.g.,20% compressed) when the strip 4202 latches to a third tooth 5422C.Accordingly, where the stabilizing structure 4200 is unable tocompletely collapse upon the application of negative pressure, or wheredifferent portions of the stabilizing structure 4200 collapse todifferent positions, the latching members 5450 of the mechanism 5402 canlatch, secure or otherwise hold the stabilizing structure 4200 orportions of the stabilizing structure 4200 in their compressedpositions, for example once negative pressure has been removed.

FIG. 44 shows another embodiment of a latching member 5460 of amechanism 5402. The latching member 5460 that can latch, lock orotherwise hold portions of the stabilizing structure when in a collapsedposition to thereby maintain the stabilizing structure 4200 in saidcollapsed position, for example, after negative pressure to the woundclosure device 5400 is ceased. The latching member 5460 is similar tothe latching member 5450, except as described below.

The latching member 5460 can have an elongate member 5410 and a latchingelement 5420. In the illustrated embodiment, the latching element 5420has more than one tooth 5422 (e.g., a plurality of teeth 5422), each ofthe teeth having an inner surface 5430 and an outer surface 5440, asdescribed above in connection with the latching member 5450 and allowingthe mechanism 5402 to latch, secure or otherwise hold the stabilizingstructure 4200 in more than one compressed state, as discussed above. Inthe illustrated embodiment, the latching element 5420 is disposed at anintermediate position between a bottom end and a top end of the latchingmember 5460. The latching element 5420 can extend through an opening5470 in a portion of the stabilizing structure 4200, such as a strip4202, so that stress provided by the coupling of the latching element5420 and the strip 4202 can be centralized in the stabilizing structure4200 such that coupling the latching members 5460 to the correspondingportions (e.g., strips 4202) of the stabilizing structure 4200 does notcause a curvature (e.g., deformation away from the plane) of thestabilizing structure 4200.

In another embodiment, the latching elements can be disposed along theface of the elongate member 5410 and can be hook members that couple toloop members on the corresponding surface (e.g., strip 4202) of thestabilizing structure 4200, such that the mechanism 5402 includes ahook-and-loop latching mechanism.

FIG. 45 shows another embodiment of a wound closure device 5480. Thewound closure device 5480 can have a stabilizing structure 4200 and haveone or more strips 4202 interconnected by one or more interveningmembers 4204 joined to the one or more strips 4202 via joints 4206. Asdiscussed above, the strips 4202 and intervening members 4204 define aplurality of cells 4210 side by side in a plane (defined by the page inFIG. 43 ), each of the cells 4210 defined between two adjacent strips4202 and two adjacent intervening members 4204 and having an opening5488 that extends from a top end to a bottom end of the stabilizingstructure 4200 in a direction perpendicular to the plane. As describedabove, the stabilizing structure 4200 can collapse along the plane suchthat the one or more strips 4202 move toward each other (e.g., adjacenteach other) as the intervening members 4204 pivot relative to the strips4202 (e.g., as the cells 4210 collapse).

With continued reference to FIG. 45 , the wound closure device 5480 canalso include a mechanism 5482 that can latch, lock or otherwise holdportions of the stabilizing structure when in a collapsed configurationto thereby maintain the stabilizing structure 4200 in the collapsedconfiguration, for example, after negative pressure to the wound closuredevice 5480 is ceased. In one embodiment, the mechanism 5482 can includeone or more first latching members 5484 attached to at least one of theone or more intervening members 4204 and one or more second latchingmembers 5486 attached to at least one of the one or more strips 4202. Inthe illustrated embodiment, a plurality of first latching members 5484are attached to a plurality of intervening members 4204, and a pluralityof second latching members 5486 are attached to a plurality of strips4202 such that a first latching member 5484 and a second latching member5486 extend into the opening 5488 of the cell 4210. In one embodiment,the first latching member 5484 extends at a non-perpendicular angle(e.g., an acute angle) relative to its corresponding intervening member4204, and the second latching member 5486 extends at a non-perpendicularangle (e.g., an acute angle) relative to its corresponding strip 4202.In one embodiment, the angle of the first and second latching members5484, 5486 relative to their corresponding intervening member 4204 andstrip 4202 is the same.

As the stabilizing structure 4200 moves to the collapsed configuration(e.g., via application of negative pressure to the wound closure device5480), the intervening member 4204 folds toward the strip 4202 so thatthe first latching member 5484 comes in contact with the second latchingmember 5486. In one embodiment, the first latching member 5484 slidablycontacts the second latching member 5486 as the intervening member 4204folds onto the corresponding strip 4202. In one embodiment, the firstand second latching members 5484, 5486 maintain the intervening member4204 and strip 4202 (and therefore the stabilizing structure 4200) inthe collapsed configuration via at least the friction force between thefirst and second latching members 5484, 5486. In another embodiment, thelatching members 5484, 5486 can have latching elements, such as thelatching elements 5420 described above. For example, one or both of thefirst and second latching members 5484, 5486 can have a curved surface(e.g., convex surface) that slides past a corresponding latching surface(e.g., convex surface) on the other of the first and second latchingmembers 5484, 5486.

In one embodiment, the first and second latching members 5402, 5482 canbe attached (e.g., adhered) to their corresponding intervening member4204 and strip 4202. In another embodiment, the first latching member5484 and intervening member 4204 can be a single piece (e.g., moldedtogether, monolithic), and the second latching member 5486 and thecorresponding strip 4202 can be a single piece (e.g., molded together,monolithic).

In one embodiment, the mechanism 5482 can have a reset or releasemechanism that can be actuated to unlatch the one or more latchingmembers 5404, 5450, 5460, 5484, 5486 from corresponding portions (e.g.,strips 4202) of the stabilizing structure 4200. For example, if themechanism 5482 inadvertently or accidentally latches at least portionsof the stabilizing structure 4200 as the stabilizing structure 4200 isfirst placed over or within the wound site. In another embodiment, ifthe surgeon wants to move at least a portion of the stabilizingstructure 4200 from a collapsed configuration, for example afternegative pressure has been removed, the surgeon can actuate the rest orrelease mechanism to allow said at least a portion of the stabilizingstructure 4200 to be moved to an expanded configuration. An operator(e.g., surgeon) can actuate the reset of release mechanism (e.g., via anactuator, such as a lever) to unlatch the one or more latching members5404, 5450, 5460, 5484, 5486 from the corresponding strips 4202. Forexample, the reset or release mechanism can move the latching element5420 of the engaged latching member 5450, 5460 away (e.g., axially away)from the strip 4202 so that the strip 4202 can move past the latchingelement 5420 allowing the stabilizing structure to be expanded from acollapsed configuration. In one embodiment, each latching member 5404,5450, 5460, 5484, 5486 can have a separate reset or release mechanism.In another embodiment, the reset or release mechanism can be actuated tounlatch a plurality of latching members 5404, 5450, 5460, 5484, 5486 atthe same time.

FIG. 46 shows one embodiment of a reset or release mechanism 5490 thatcan be used, for example, with the one or more latching members 5450,5450. In the illustrated embodiment, the reset or release mechanism 5490can include an arch portion 5492 that can interconnect two latchingmembers 5404, 5450. An operator (e.g., surgeon) can actuate the reset orrelease mechanism 5490 to unlatch the one or more latching members 5404,5450 from portions (e.g., strips 4202) of the stabilizing structure 4200by applying an upward force on the arch portion 5492 (e.g., via asurgical instrument inserted underneath the arch portion 5492, such asforceps or other surgical instruments in the operating room, or via theoperator's fingers), thereby lifting the latching element 5420 of theinterconnected latching members 5404, 5450 from engagement with theportion (e.g., strips 4202) of the stabilizing structure 4200.

In one embodiment, two latching members 5404, 5450 can be interconnectedby the arch portion 5492. In another embodiment, more than two latchingmembers 5404, 5450 can be interconnected by arch portions 5492 disposedbetween adjacent latching members 5404, 5450. For example, where thereset and release mechanism 5490 is to be operated by using theoperator's fingers, three or four arch portions 5492 could interconnectadjacent latching members 5402, 5450, to allow facilitate lifting of thearch portions 5492 as described above. In one embodiment, the archportion 5492 can be proud of (e.g., can protrude from) the end (e.g.,top end) of the stabilizing structure 4200 by an amount sufficient toallow an operator to insert either a surgical instrument or theoperator's finger(s) under the arch portion 5492 to lift the latchingmembers 5404, 5450 from engagement with the portion (e.g., strips 4202)of the stabilizing structure 4200, as discussed above. In oneembodiment, the profile of the arch portion 5492 can be as low aspossible while allowing an operator to insert at least a portion of asurgical instrument, or the user's finger(s), under the arch portion5492 so as not to impede the dynamic contraction or collapse of thestabilizing structure 4200 (e.g., via drag exerted by the arch portions5492 on a foam portion disposed above the stabilizing structure 4200).Though the reset or release mechanism 6201 is described above inconnection with the latching members 5404, 5450, one of skill in the artwill recognize that the reset or release mechanism 5490 described abovecould also be used with the latching members 5404, 5450.

The latching members described above can be made of a resilientmaterial, such as a plastic or polymer material. However, other suitablematerials can be used.

Stabilizing Structures and Wound Closure Devices of FIGS. 47-51

In certain embodiments, it may be advantageous to minimize the number ofsteps needed for a clinician to position a stabilizing structure asdescribed above and other components into a wound. For example, it maybe desirable to eliminate one or more steps relating to placement of theporous layers 5102, 5116, the porous layer 5106 and/or the anchoringlayer 5108, as depicted above in FIGS. 10A-10C.

In some embodiments, while the porous layers 5102, 5116 and/or 5106 ofFIGS. 10A-10C may be useful for transmitting fluid between upper andlower surfaces of the stabilizing structure, in another embodiment withor without one or more of such layers, the stabilizing structure itselfmay include a system of pores, channels or grooves running from thelower surface to the upper surface, e.g., along some or all of thevertical walls within some or all of the cells to allow liquids tobridge the stabilizing structure using capillary action. For example,channels or grooves may be moulded, etched or deposited onto surfaces ofthe stabilizing structure. For example, channels could be made bydeposition as described in PCT Publication No. WO 2008/150542 A1, theentirety of which is hereby incorporated by reference. For example,referring now to FIGS. 2A-2I above, the material 4216 may be molded soas to contain vertical tubes running from the lower to the upper surfaceof the stabilizing structure either within the elongate strips 4202 orwithin the intervening members 4204, allowing fluid transfer. Forexample the system of pores, channels or grooves could be present on theindividual supporting segments so as to allow liquid to travel from thelower surface to the upper surface if the soft polymer is selectivelymolded over only parts of the stabilizing structure thus leaving thesepores, channels or grooves exposed.

Essentially, using such an approach will provide a route with a workingcapillary cross-section. Providing such pathways either along thesurfaces of the stabilizing structure or within it will mean that evenafter cutting of the stabilizing structure to a desired size, thesepathways will still exist in the as-sized structure. In one embodiment,the one or more pathways provided by the pores, channels or grooves ofthe stabilizing structure can be hydrophilic to facilitate capillaryaction by liquid (e.g., from the wound side), thereby allowing saidliquid to bridge the stabilizing structure, as discussed above. Forexample, said soft polymer discussed above can be a soft hydrophilicpolymer (e.g., acrylic polymer with hydrophilic groups, such as ethylhydroxyl), hydrophilic silicone, etc. However, other suitablehydrophilic materials known in the art can be used. Such hydrophilicmaterials are described, for example, in Mechanical Properties of aHydrophilic Acrylic Polymer, W. J. O'Brien, J. Hermann, & T. H.Shepherd, J. Biomed. Mater. Res. Vol. 6, PP. 15-24 (1972). In otherembodiments, a hydrophilic coating (e.g., hydrophilic silicone) can beapplied to one or more surfaces of the stabilizing structure. Anysuitable hydrophilic coating know in the art can be used.

Other examples of such soft polymers include copolymeric polymers suchas hybrids derived from two or more monomeric species, includingalternating, periodic, statistical, random, block, linear, branched,star, graft and pendant copolymers. Entangled systems includeinterpenetrating networks (IPNs) and semi-interpenetrating networks(SIPNs). These polymers can incorporate both organic and inorganicmoieties. Examples of hybrid organic-inorganic polymeric systems thathave used both siloxane and organic units include: acrylatefunctionalized siloxane copolymers; hybrid grafts where organic polymersare grafted onto a polysiloxane chain or where siloxanes are graftedonto organic polymers, for example in silane graft technology for crosslinkable high density polyethylene (HDPE) where hybrid grafts have beenused to allow the cross linking of organic polymers through siloxanebond formation; hybrid block copolymers, for examplesilicone-polycarbonate block copolymers; and copolymers of hybrids ofsilicone and ethylene copolymers, cross-linked with vinyl-containingsilicone copolymers.

IPNs represent a class of hybrid polymeric systems that use acombination of mechanical entanglement and crosslinking in which onepolymer is cured about another. These include thermoplastics entangledwith platinum catalyzed addition cure silicones, such assilicone-urethane IPNs and semi-IPNs including silicone-urethane andsilicone-polyamide systems; hydrophilic components immobilized in asilicone polymer; and silicone polymer cured about a non-reactivepolymer of comparable adhesion.

In another embodiment the soft polymer described above, molded over partor all of the stabilizing structure 4200 of FIGS. 2A-2I may be selectedso as to retain the required material properties with regards to therequired feel and function of the device but also to function as theporous material.

Examples of suitable elastomers may be found in U.S. Publication No.2010/0075056, the entirety of which is hereby incorporated by reference.For example, porous polymers synthesized within high internal phaseemulsions (HIPE), sometimes referred to as “polyHIPE” within thescientific literature, can be used. In another example, highly porouselastomer-silsesquioxane nanocomposites synthesized within high internalphase emulsions or polydimethylsiloxane (PDMS) elastomerformed withthree-dimensional (3D) micro-channels, can be used.

In another embodiment the porous materials such as the foam describedabove, wicking layers, acquisition distribution layers (ADLs),elastomers or other materials may be provided on internal surfaces andor on the external surfaces of the stabilizing structure. Wicking oracquisition distribution layers (ADLs) are able to wick fluid such aswound exudate and would serve to transport liquid from the lower face tothe upper face of the stabilizing structure. Some embodiments of the ADLmay comprise viscose, polyester, polypropylene, cellulose, or acombination of some or all of these, and the material may beneedle-punched. Some embodiments of the ADL may comprise polyethylene inthe range of 40-150 grams per square meter (gsm). Examples of ADLs mayinclude: Dry Web TDL2 from Libeltex BVBA with a basis weight of 55 gsm,SlimCore TL4 from Libeltex BVBA with a basis weight of 150 gsm & 90 gsm,Dry Web T28F from Libeltex BVBA with a basis weight of 50 gsm &MH080.121 from Glatfelter with a basis weight of 80 gsm.

Advantages of these approaches is that they may overcome the requirementto use foam or other porous material on the outer perimeter of thestabilizing structure, especially foam or porous material applied aftersizing of the stabilizing structure, to allow fluid transfer and wouldalso allow for transfer across all (or selected) vertical members orwalls within the stabilizing structure.

In any of these embodiments, anchors or an anchor layer may further beprovided on internal (as well as external) surfaces of the stabilizingstructure, alone or in combination with the embodiments described above.For example, anchors may be provided inside cells of the stabilizingstructure on elongate strips extending lengthwise across the stabilizingstructure. Thus, when the stabilizing structure is cut the resultingstructure would have anchors on the two lengthwise surfaces on theresulting outer perimeter.

In another embodiment, anchors may be incorporated into the individualsupporting segments 4214 described above in relation to FIG. 2A-2I whichcomprise part of the longitudinal strips 4202. In such embodiments, thebase of the anchors may serve as the individual supporting segments4214, the base optionally encapsulated or partly encapsulated within aflexible polymer.

FIG. 47 illustrates one embodiment wherein a section of a stabilizingstructure (which may be any of the stabilizing structures describedherein) comprises at least two elongate strips 2302 and 2304 separatedby intervening members 2306 to define a plurality of cells 2308. One,two, three or all of the vertical walls of the cells 2308 defined by thestrips and intervening members may be covered by a porous material suchas foam, an elastomer, or other material or structure described above toprovide for fluid transfer. Preferably, even though internal walls orcovered, the cells are still open between the upper surface and lowersurface of the stabilizing structure in order to facilitate to collapseof the structure. As illustrated in FIG. 48 , a layer of porous material2310 such as foam can be applied to internal surfaces of the stabilizingstructure using an adhesive layer 2306. The porous layer 2310 mayfurther have anchors or an anchoring layer attached to all or portionthereof, or not at all.

As illustrated in FIG. 48 , the porous layer 2310 may be applied tointernal surfaces of adjacent cells. FIG. 48 also illustrates that theporous layer 2310 may be applied to an external surface of strip 2304,if strip 2304 defines an outer perimeter of the structure. In someembodiments where the cells have four internal walls, two defined bystrips 2302 and 2304 and two defined by adjacent intervening members2306, one embodiment provides for one of the four internal walls to becovered with the porous layer 2310. In other embodiments, the porouslayer may have an “n” shape covering three of four walls, for example anintervening member wall and the two adjacent walls formed by the strips2302 and 2304. Other variations are also possible. Accordingly, even ifthe stabilizing structure 2300 is cut to an appropriate size, thestructure advantageously will have a resulting outer perimeter thatincludes at least a portion thereof covered by a porous material.

FIGS. 49A-49B illustrate one cell 2408 of a stabilizing structure 2400,which can be similar to the stabilizing structure 2300 and can have aplurality of cells 2408 arranged in rows as described above, the cell2408 having wall portions that define portions of two elongate strips2406, and intervening members 2402, 2404 that interconnect the elongatestrips 2406. A strip 2406 can have a medial surface 2406 a and a lateralsurface 2406 b. Medial or medially-facing as used herein refers to adirection toward a center of the stabilizing structure, and lateral orlaterally-facing (sometimes also referred to herein as distal ordistally-facing) as used herein refers to a direction outward from acenter of the stabilizing structure.

In one embodiment, a porous layer 2410, which can be similar to theporous layer 2310 described above, can be disposed on at least a portionof the medial surface 2406 a. Accordingly, when the size of thestabilizing structure 2400 is adjusted (e.g., by cutting one or morestrips) to better fit over or within the wound site, the lateral surface(e.g., distal surface) 2406 b of the one or more cells 2408 of thestabilizing structure 2400 can have a substantially flat or planar (andin some embodiments smooth) surface.

In one embodiment, the porous layer 2410 can be disposed over less thanthe entire (e.g., less than 90%, less than 80%, less than 70%, less than50%, less than 30%, less than 20%, less than 10%) width of the medialsurface 2406 a, and can extend from a bottom end to a top end of themedial surface 2406 a. In one embodiment, the porous layer 21410 can bedisposed on a portion of said medial surface 2406 a that defines onequadrant (or less than one quadrant) of the cell 2408.

With continued reference to FIG. 49A, the porous layer 2410 can bedisposed on the medial surface 2406 a so as to not restrict movement ofthe one or more walls of the cell 2408 as the cell 2408 collapses whenthe stabilizing structure 2400 moves toward a collapsed position, suchas during the application of negative pressure thereto. For example, theporous layer 2410 can be disposed on a portion of the medial surface2406 a that defines an obtuse angle (e.g., between strip 2406 andintermediate member 2404) as the cell 2408 collapses, thereby avoidingrestricting the collapsing movement of the cell 2408. It will beappreciated that the porous layer 2410 can be placed in other locations,such as on an inwardly-facing surface of one of the intervening members2402, 2404.

FIG. 49B shows the cell 2408 moving toward a collapsed position, wherethe cross-section of the cell 2408 is shaped like a parallelogram. Saidcollapsing motion can occur as a force F (e.g., due to negative pressureapplied to the stabilizing structure 2400) is applied on the lateralface 2406 b and the face of the intervening member 2402. In theillustrated embodiment, as the medial surface 2406 a moves toward theintervening member 2402, the porous layer 2410 facilitates the flow offluid therethrough while not interfering or restricting the collapsingmovement of the cell 2408.

FIG. 50 schematically illustrates a bird-eye view of a plurality ofcells 2408 of the stabilizing structure 2400, where porous layers 2410are disposed on the medial surfaces 2406 a (e.g., proximal surfaces) ofthe strips 2406 of the stabilizing structure 2400. When strips 2406 areremoved (e.g., cut), along with associated intervening members, from thestabilizing structure 2400, the lateral surface 2406 b (see FIG. 51 ) ofthe remaining strips 2406 can be substantially flat or planar while themedial surface 2406 a of the strips 2406 has the porous layer 2410(e.g., disposed in one or more of the cells 2408 of the stabilizingstructure 2400). That is, if certain elongate strips (and correspondingintervening members) are removed from lateral portions of thestabilizing structure, more medial strips will remain that include theporous layers 2410. After sizing of the stabilizing structure shown inFIG. 16 , elongate strips 2406 may remain having flat or substantiallysmooth outer or lateral surfaces. Such surfaces may not include a porouslayer 2410, and may be used for attachment of an anchoring layer asdescribed above thereto.

FIG. 51 schematically illustrates the stabilizing structure 2400, whereone or more anchors (e.g., an anchor layer) 2500 is disposed on at leasta portion of lateral surfaces (e.g., distal surfaces) 2406 b of thestrips 2406. Accordingly, when strips 2406 are removed (e.g., cut) fromthe stabilizing structure 2400, the lateral surfaces 2406 b (e.g.,distal surfaces) of the strips 2406 will have said anchors thereon,thereby avoiding having to attach an anchor layer to said lateralsurfaces 2406 b following the resizing of the stabilizing structure2400. Said anchors 2500 can be tissue anchors, as described above.

In one embodiment, the one or more anchors or anchor layer 2500 can bedisposed on the lateral surfaces (e.g., distal surfaces) 2406 b of thestrips 2406 so as to not restrict movement of the one or more walls ofthe cells 2408 of the stabilizing structure 2400 as the cells 1408collapse when the stabilizing structure 2400 moves toward a collapsedposition, such as during the application of negative pressure thereto.For example, the anchors 2500 can be disposed on a portion of thelateral surface 2406 b that defines an obtuse angle (e.g., between strip1406 and intermediate member 2404, 2402) as the cell 2408 collapses,thereby avoiding restricting the collapsing movement of the cell 2408.

In one embodiment, the one or more anchors or anchor layer 2510 can bedisposed over less than the entire (e.g., less than 90%, less than 80%,less than 70%, less than 50%, less than 30%, less than 20%, less than10%) of the lateral surface 2406 b. In one embodiment, the anchor layer2500 can be disposed on a portion of said lateral surface 2406 b thatdefines one quadrant (or less than one quadrant) of the cell 2408.

In one embodiment, the stabilizing structure 2400 can have both one ormore porous layers 2410 on medial surfaces 2406 a, and one or moreanchors 2500 on lateral surfaces 2406 b of the strips 2400. Accordingly,when strips 2406 are removed (e.g., cut) from the stabilizing structure2400, the lateral surfaces 2406 b (e.g., distal surfaces) of the strips2406 will have said anchors thereon and the medial surfaces 2406 a(e.g., proximal surfaces) will have porous layers 2410 thereon, therebyavoiding having to attach an anchor layer 2500 to said lateral surfaces2406 b or a porous layer 2410 to said medial surfaces 2406 a followingthe resizing of the stabilizing structure 2400.

The Anchoring Clips of FIGS. 52A-58B

FIGS. 52A-52E illustrate multiple views of stabilizing clips that may beattached to the stabilizing structures of FIGS. 2A-5D, 13A-14C, and16-18C or other embodiments described herein. As illustrated in FIG.52A, in some embodiments, stabilizing clip 7000 may comprise anattachment portion 7002 that allows it to “clip” onto a wall of astabilizing structure, such as upon an elongate member or an interveningmember. Stabilizing clip 7000 may also comprise a securing portion 7004that can extend above or below tissue layers to aid in securing thestabilizing structure 6000 to the surrounding tissue. The securingportion 7004 may extend from a lower end of the attachment portion 7002,at the closed end of the attachment portion. For example, when astabilizing structure, such as stabilizing structure 6000 of FIG. 14A,is placed into an abdominal wound, the underlying viscera may tend toexpand and push the stabilizing structure upwards and out of theabdominal wound. Such an occurrence is undesirable because, as describedabove, the stabilizing structure is suited to be placed within anabdominal wound whereby the stabilizing structure can draw the edges ofthe wound together. To alleviate the outward pressure of the expandingviscera, in some embodiments as illustrated by FIG. 52B, before placingthe stabilizing structure within the wound, the stabilizing clips 7000may be attached to the underside of the stabilizing structure 6000. Thesecuring portion 7004 of the stabilizing structure 6000 may then extendoutward from the stabilizing structure and under the surrounding tissue7010, for example the fascia 7012.

In some embodiments, the clips are rigid, therefore once the securingportion 7004 is extended below the fascia 7012, the securing portion canabsorb upward force from the swelling viscera while maintaining thestabilizing structure 6000 in place within an abdominal wound. Infurther embodiments, the securing portion may be semi-rigid or soft. Insome embodiments, the clip can be made from any suitable materialincluding, for example, plastics, ABS, PU, PE, PP, PET, silicone, Nylon,or other suitable materials known in the art. Further, the clip can bemade of metals including, for example, titanium, stainless steel,Inconel, or other suitable material known in the art. Additionally, theclip can be made of composites including, for example, carbon fiber,Kevlar, reinforced plastics, or other suitable material known in theart.

The stabilizing clip may be clipped to the top or the bottom of thestabilizing structure, thereby extending the securing portion over thetop or below the surrounding tissue. In some embodiments, an anchoringlayer such as those described elsewhere in the specification,particularly in FIGS. 3-5D, may be attached to the stabilizing clip. Oneof skill in the art with recognize that such an anchoring layer may beapplied to the stabilizing clip in any suitable manner, such as aroundor under the stabilizing clip.

In some embodiments, the stabilizing clips are radiopaque, such thatthey are easily identifiable if lost within the body. To further makethe stabilizing clips easier to find, the stabilizing clips may beattached or tied together in a suitable manner. In some embodiments twostabilizing clips are attached together, three stabilizing clips, fourstabilizing clips, or more than four stabilizing clips attachedtogether.

In embodiments, the stabilizing structure may have notches such that thestabilizing clips may be help more firmly over the notch. Thestabilizing clip may further have an additional protrusion that servesto prop open the stabilizing structure such that the stabilizingstructure cannot fully close. Instead of or in tandem with a protrusion,the stabilizing clip may have a loop that acts to prop open thestabilizing structure. In some embodiments, the stabilizing clip propsopen the stabilizing structure at least: 10%, 20%, 30%, 40%, 50%, ormore than 50%.

FIG. 52C illustrates an embodiment of stabilizing clip 7006, similar tothe stabilizing clip of FIG. 52A. Stabilizing clip 7000 may comprise anattachment portion 7002 that loops over the top of a wall of astabilizing structure. In this way, the stabilizing clip 7000 will bemore difficult to dislodge from the stabilizing structure. As with theother stabilizing clip embodiments illustrated in FIG. 52A, thestabilizing clip of FIG. 52B may comprise a securing portion 7004 thatextends below a layer of tissue such as the fascia, to maintain thestabilizing structure in place. The securing portion 7004 may extendfrom a lower end of the attachment portion 7002, however, in thisinstance the lower end of the attachment portion is the open end becausethe stabilizing clip “clips” onto the stabilizing structure from thetop.

FIG. 52D depicts another embodiment of a stabilizing clip 7008, similarto the stabilizing clip embodiments of FIGS. 52A-B. Stabilizing clip7008 has securing portions 7004, 7010 on both the upper and lowerportions of the stabilizing clip. The stabilizing clip may have a firstsecuring portion 7010 extending outward from an upper end of theattachment portion and a second securing portion 7004 extending outwardfrom a lower end of the attachment portion. Therefore, once attached toa stabilizing structure, stabilizing clip 7008 may more tightly securethe stabilizing structure in place because the securing portions extendboth above and below various tissue layers such as the fascia. FIG. 52Eshows side views of stabilizing clips 7000, 7006, and 7008, while FIG.52F shows a top front view of stabilizing clips 7000, 7006, and 7008.

FIGS. 53A-C illustrate embodiments of stabilizing clips, similar to thestabilizing clips depicted in FIGS. 52A-F, attached to a stabilizingstructure 7100 similar to the stabilizing structures of FIGS. 2A-2I and5A-5D. Here the stabilizing clip 7000, 7006, 7008 may be attached to thebottom of a stiffer portion 7102 of the stabilizing structure. However,the stabilizing clip may also be attached to the softer portion of thestabilizing structure. In some embodiments, more than one stabilizingclip will be used. For example, a single stabilizing structure maycontain 2 or more of one type of stabilizing clip on one side, three ormore stabilizing clips, four or more stabilizing clips, five or morestabilizing clips, six or more stabilizing clips, or more than sixstabilizing clips. Sometimes when using more than one clip, only onetype of clip is used, however, at other times more than one type of clipmay be used. In certain embodiments, there will only be one stabilizingclip per wall of the stabilizing structure; however, further embodimentsmay call for multiple stabilizing clips per wall of the stabilizingstructure.

FIGS. 54A-54E are pictures of embodiments of stabilizing structures 8000similar to the stabilizing structures of FIGS. 14A-C. Similar to FIGS.53A-C, stabilizing clips 8002 may be attached to the stabilizingstructure to secure the stabilizing structure within the wound. Asdescribed herein this section and elsewhere in the specification, thestabilizing clips 8002 may extend outward from the stabilizing structureinto the surrounding tissue and hold the stabilizing structure in placewithin the abdominal wound.

FIGS. 54F-G are illustrations of the stabilizing structure embodimentsof FIGS. 54A-18E, however, the embodiments within these illustrationsincludes a larger number of stabilizing clips.

FIGS. 55A-G illustrate an embodiment of stabilizing clip 9006, similarto the stabilizing clip of FIG. 52C. Stabilizing clip 9006 may comprisean attachment portion 9002 that loops over the top of a wall of astabilizing structure. As with the other stabilizing clip embodimentsillustrated in FIG. 52C, the stabilizing clip of FIGS. 55A-G maycomprise a securing portion 9004 that extends below a layer of tissuesuch as the fascia, to maintain the stabilizing structure in place. Thesecuring portion 9004 may extend from a lower end of the attachmentportion 9002. The securing portion 9004 can include grippers 9008. Thegrippers 9008 can assist in attaching the securing portion to thesurrounding tissue. The securing portion 9004 and the grippers 9008extend below a layer of tissue such as the fascia, to maintain thestabilizing structure in place. The tissue grippers 9008 can be similarto the tissue anchors described with reference to FIGS. 5A-D. The tissuegrippers 9008 can be formed of the same material as the stabilizingclip. In some embodiments, the grippers 9008 can be formed of adifferent material than the material used for construction of thestabilizing clip. FIGS. 55A-G illustrate grippers 9008 on a top surface9010 of the securing portion 9004. In some embodiments, the grippers9008 may be provided on the bottom surface 9011, sides 9012, or frontsurface 9013 of the securing portion. Further, in some embodiments, theattachment portion of the stabilizing clips may include grippers thatcan assist in securing the stabilizing structure.

FIGS. 56A-J illustrate an embodiment of stabilizing clip 10006, similarto the stabilizing clip of FIGS. 55A-G. Stabilizing clip 10006 maycomprise an attachment portion 10002 that loops over the top of a wallof a stabilizing structure. As with the other stabilizing clipembodiments illustrated in FIGS. 55A-G, the stabilizing clip of FIGS.56A-J may comprise a securing portion 10004 that extends below a layerof tissue such as the fascia, to maintain the stabilizing structure inplace. The securing portion 10004 may extend from a lower end of theattachment portion 10002. The stabilizing clip 10006 can include a stepor recess 10010 at the intersection of the securing portion 10004 andthe attachment portion 10002 or where the securing portion 10004 extendshorizontally from the attachment portion 10002. In some embodiments, asdepicted in FIGS. 56A-J, the securing portion 10004 may include grippers10008 to assist in attaching the securing portion to the surroundingtissue. In other embodiments, the stabilizing clip 10006 with the stepor recess 10010 may be used with a securing portion 10004 withoutgrippers 10008 on the surface of the securing portion 10004. The step10010 can provide a step or recess in the stabilizing clip toaccommodate a foam and/or other material positioned below the matrix,similar to foam layer 5102 described with reference to FIG. 10A or otherembodiments described herein. The step 10010 allows the stabilizing clip10006 attached to the matrix stabilizing structure 10013 to fit around apiece of foam that is placed below the stabilizing structure 10013 whichmay be slightly larger than the stabilizing structure 10013. In someembodiments, the size of the step can be changed to accommodate thevarious foam sizes.

FIGS. 56H-J are pictures of the stabilizing clip 10006 attached to astabilizing structure or matrix support 10013. The stabilizing structure10013 is positioned above a foam layer 10011. The foam layer 10011 islarger than the stabilizing structure 10013. The step or recess 10010 ofthe stabilizing clip fits around the larger foam layer 10011. The stepor recess 10010 may allow the stabilizing clip to secure the stabilizingstructure within the wound without applying excess pressure on the foamlayer that is slightly larger than the stabilizing structure. The stepor recess may be provided at any vertical position along the attachmentportion of the stabilizing clip to accommodate various depths of foams,stabilizing structures, and/or stabilizing clips.

FIGS. 57A-J illustrate an embodiment of stabilizing clip 11006, similarto the stabilizing clip of FIG. 52C. As with the other stabilizing clipembodiments illustrated in FIG. 52C, stabilizing clip 11006 may comprisean attachment portion 11002 that loops over the top of a wall of astabilizing structure and a securing portion 11004 that extends below alayer of tissue to maintain the stabilizing structure in place. Thestabilizing clip 11006, as illustrated in FIGS. 21A-J, may include afoot 11012 to latch to the bottom of the stabilizing structure 11013.The foot 11012 may be provided at the end 11014 of the loop of theattachment portion 11002 that loops over the top of a wall of thestabilizing structure 11004. The foot 11012 can provide strengthening inthe corner of the stabilizing clip 11006. The stabilizing clip 11006with the foot 11012 improves the stability and strength of thestabilizing clip 11006. FIGS. 57H-57J are pictures of the stabilizingclip 10006 attached to the stabilizing structure 10013. The stabilizingclip 11006 can include a foot and grippers as illustrated in someembodiments in FIGS. 55A-G.

FIGS. 58A-B are pictures of embodiments of a stabilizing device. Thestabilizing device 12000 can include grippers 12008 on an outsidesurface of the stabilizing device. The grippers can be similar to thetissue anchors described with reference to FIGS. 5A-D. Examples of suchgrippers may be available from Alfatex. In one embodiment, an anchoringlayer may be provided comprising a 3D fabric material or portionthereof. For example, a 3D fabric may comprise a woven fabric layerprovided along a first plane and a plurality of monofilaments extendingperpendicularly from or at an angle relative to the woven fabric layer.The woven fabric layer may be configured to be attached to directly orindirectly to the outside of a stabilizing structure as describedelsewhere in this specification and in the applications incorporated byreference. Monofilaments may have a mushroom-shaped head or other shapesconfigured to engage tissue surrounding the stabilizing structure. Thehead of the monofilaments may be similar to a peened rivet with aflatted head and extended edges that engage the surrounding tissues. Ifthe monofilaments protrude at an angle then the material creates moregrip in one direction of shear than another. This directionality meansthe anchoring layer and monofilaments can be positioned on a stabilizingstructure so that the shear acts to stop the device being forced up orout of the wound by the viscera but can be easily released by pushing itdown.

As described above, a stabilizing structure such as those describedherein this section or elsewhere in the specification may be securingwithin a wound through the use of any stabilizing clip described hereinthis section or elsewhere in the specification. The following steps neednot be completed in any particularly order, but are provided in thefollowing order as an example. As depicted above in relation to FIG.10A, the stabilizing structure may first be sized for a particular woundby trimming or removing portions of the stabilizing structure. Uponsizing the stabilizing structure to a particular wound shape,stabilizing clips may then be attached to the stabilizing structure.Then, the stabilizing structure is partially closed so as to facilitateplacing the stabilizing structure into an abdominal wound and securingthe stabilizing clips such that the clips extend under the fascia layer.Since the fascia is a relative strong tissue, by securing thestabilizing clips underneath the fascia, the stabilizing structurecannot be pushed up in a direction out of the wound by the underlyingviscera. As described above, any number of stabilizing clips may be usedand they may extend above and/or below various layers of tissue.

Although this disclosure describes certain embodiments, it will beunderstood by those skilled in the art that many aspects of the methodsand devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure.Indeed, a wide variety of designs and approaches are possible and arewithin the scope of this disclosure. No feature, structure, or stepdisclosed herein is essential or indispensible. Moreover, whileillustrative embodiments have been described herein, the scope of anyand all embodiments having equivalent elements, modifications,omissions, combinations (e.g., of aspects across various embodiments),substitutions, adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. While certainembodiments have been described, these embodiments have been presentedby way of example only, and are not intended to limit the scope ofprotection.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example described inthis section or elsewhere in this specification unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The protection is notrestricted to the details of any foregoing embodiments. The protectionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of asubcombination.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, or thatall operations be performed, to achieve desirable results. Otheroperations that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionaloperations can be performed before, after, simultaneously, or betweenany of the described operations. Further, the operations may berearranged or reordered in other implementations. Those skilled in theart will appreciate that in some embodiments, the actual steps taken inthe processes illustrated and/or disclosed may differ from those shownin the figures. Depending on the embodiment, certain of the stepsdescribed above may be removed, others may be added. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure. Also, theseparation of various system components in the implementations describedabove should not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. Not necessarily all such advantages maybe achieved in accordance with any particular embodiment. Thus, forexample, those skilled in the art will recognize that the disclosure maybe embodied or carried out in a manner that achieves one advantage or agroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements, and/or steps areincluded or are to be performed in any particular embodiment.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.

The scope of the present disclosure is not intended to be limited by thespecific disclosures of preferred embodiments in this section orelsewhere in this specification, and may be defined by claims aspresented in this section or elsewhere in this specification or aspresented in the future. The language of the claims is to be interpretedbroadly based on the language employed in the claims and not limited tothe examples described in the present specification or during theprosecution of the application, which examples are to be construed asnon-exclusive.

1-190. (canceled)
 191. A porous wound dressing for use in negative-pressure therapy of wounds, comprising: an outer edge which defines an oval outer shape of the wound dressing, the wound dressing comprising a major axis and a minor axis; a plurality of arc-shaped pre-cut lines, the pre-cut lines configured to serve for cutting the wound dressing to size in order to adapt the wound dressing to the size of a wound; wherein each of the pre-cut lines extends asymmetrically with respect to the major axis and/or to the minor axis and encloses, together with a portion of the outer edge, a segment of the wound dressing that is designed for separation from the wound dressing and for subsequent use in the negative-pressure therapy of wounds, wherein individual segments are arranged asymmetrically with respect to the major axis and/or to the minor axis and comprise an oval outer shape which corresponds to the oval outer shape of the wound dressing, such that an observer is able to readily recognize the oval outer shape of the wound dressing in the oval outer shape of the segment, and wherein the arc-shaped pre-cut lines are arranged at regular intervals from one another and extend at least approximately parallel to one another and to a further portion of the outer edge of the wound dressing, such that an oval-shaped division of the wound dressing into the segments is obtained.
 192. The porous wound dressing of claim 191, wherein the porous wound dressing comprises foam.
 193. The porous wound dressing of claim 191, wherein individual pre-cut lines comprise markings to facilitate removal of individual segments.
 194. The porous wound dressing of claim 191, wherein individual pre-cut lines comprise scoring to facilitate removal of individual segments.
 195. The porous wound dressing of claim 191, wherein individual pre-cut lines comprise partial cuts through a thickness of the porous wound dressing.
 196. The porous wound dressing of claim 191, wherein individual pre-cut lines comprises full cuts through the thickness of the porous wound dressing.
 197. The porous wound dressing of claim 191, wherein the porous wound dressing further comprises tissue anchors.
 198. The porous wound dressing of claim 197, wherein the tissue anchors are configured to be exposed once a segment is removed.
 199. The porous wound dressing of claim 191, wherein the porous wound dressing comprises three or more pre-cut lines.
 200. The porous wound dressing of claim 198, wherein the porous wound dressing comprises six pre-cut lines.
 201. The porous wound dressing of claim 191, wherein the individual pre-cut lines extend asymmetrically with respect to both the major axis and the minor axis.
 202. A wound cover kit for use in negative-pressure therapy of wounds, comprising: a wound contact layer configured to be placed directly against a wound; a wound cover configured to be cover and seal the wound; and a wound dressing comprising: an outer edge which defines an oval outer shape of the wound dressing, the wound dressing comprising a major axis and a minor axis, a plurality of arc-shaped pre-cut lines, the pre-cut lines configured to serve for cutting the wound dressing to size in order to adapt the wound dressing to the size of a wound, wherein each of the pre-cut lines extends asymmetrically with respect to the major axis and/or to the minor axis and encloses, together with a portion of the outer edge, a segment of the wound dressing that is designed for separation from the wound dressing and for subsequent use in the negative-pressure therapy of wounds, wherein individual segments are arranged asymmetrically with respect to the major axis and/or to the minor axis and comprise an oval outer shape which corresponds to the oval outer shape of the wound dressing, such that an observer is able to readily recognize the oval outer shape of the wound dressing in the oval outer shape of the segment, and wherein the arc-shaped pre-cut lines are arranged at regular intervals from one another and extend at least approximately parallel to one another and to a further portion of the outer edge of the wound dressing, such that an oval-shaped division of the wound dressing into the segments is obtained.
 203. The wound cover kit of claim 202, wherein the wound dressing is porous.
 204. The wound cover kit of claim 203, wherein the wound dressing comprises foam.
 205. The wound cover kit of claim 202, wherein individual pre-cut lines comprise markings to facilitate removal of individual segments.
 206. The wound cover kit of claim 202, wherein individual pre-cut lines comprise scoring to facilitate removal of individual segments.
 207. The wound cover kit of claim 202, wherein individual pre-cut lines comprise partial cuts through a thickness of the porous wound dressing.
 208. The wound cover kit of claim 202, wherein individual pre-cut lines comprises full cuts through the thickness of the porous wound dressing.
 209. The wound cover kit of claim 202, wherein the wound dressing further comprises tissue anchors.
 210. The wound cover kit of claim 209, wherein the tissue anchors are configured to be exposed once a segment is removed. 